Aspiration Thrombectomy System and Method for Removing Thrombus with an Aspiration Catheter

Abstract

A thrombus removal system includes: a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion; a vacuum source; a discharge liquid source; and a vacuum and exhaust control system configured to cyclically connect or disconnect the vacuum source and the discharge liquid source to vary the vacuum level at the distal end and substantially prevent forward flow. The vacuum source and the discharge source are fluidly connected to a vacuum valve and an exhaust valve, respectively. A manifold connects the proximal portion to the vacuum source and the exhaust source through valves. During each cycle, control of the valves prevents forward flow from the distal portion at the distal end. Each cycle may have states including only vacuum, first double-closed, only exhaust, and second double-closed. The time of the double-closed state cannot be greater than 30 ms.

Description

Technical Field

[0001] The systems, devices, and methods of the present invention pertain to the field of thrombus removal. The present disclosure relates to a thrombus aspiration removal system and a method for removing thrombus with an aspiration catheter. Background Art

[0002] Ischemic stroke is typically caused by a blood clot that obstructs or blocks the blood vessels in the brain. This obstruction prevents blood from flowing to the brain. Within minutes, brain cells begin to die, leading to brain damage or death if not treated promptly. The costs associated with removing the clot are substantial. Most treatments involve thrombectomy: removing the clot by aspiration, mechanical retrieval, or a combination of both.

[0003] Aspiration removal is performed by placing a vacuum source (e.g., an aspiration or vacuum catheter) upstream of the clot and pulling the clot into or against the distal end of the catheter. Conceptually, aspiration is effective, but several significant problems arise in practice. The basic construction of an aspiration catheter includes a hollow catheter of a certain length, the proximal end of which is fluidly connected to a vacuum pump or an aspiration pump. In this construction, the operation of the aspiration pump causes the fluid and particles at the distal end of the catheter to enter the distal opening of the hollow cavity and proceed proximally towards or into the cavity of the aspiration pump. Conventional aspiration catheters are threaded through a balloon guiding catheter. In an exemplary procedure, the balloon of the guiding catheter is guided into the internal carotid artery of the brain. The balloon is inflated to occlude the blood vessel. The aspiration catheter is threaded through the balloon guiding catheter and exits the distal end of the guiding catheter through the balloon. The distal end of the aspiration catheter is advanced to the clot that obstructs the cerebral blood vessel. The aspiration connected to the aspiration catheter is opened to cause reverse flow. Ideally, the system aspirates the entire clot from the neurovascular system and into the proximal end of the aspiration catheter so that the extraction and reconstruction of blood flow can be confirmed. However, in practice, this rarely occurs.

[0004] The diameter of a thrombus is typically larger than the diameter of the catheter used for aspirating the thrombus. For aspiration to be successful, the thrombus must deform to conform to the inner diameter of the aspiration catheter. During conventional aspiration, applying a vacuum generally sucks a portion of the thrombus into the distal opening of the lumen of the aspiration catheter, thereby deforming some of the thrombus to the inner diameter of the catheter. At this point, the thrombus is either completely retained, partially retained inside the aspiration catheter, or at the distal opening of the aspiration catheter, and this situation can be referred to as obstruction or clogging. In effect, the distal end becomes a suction cup gripper for the clot. When this occurs, the only option for the surgeon is to use the aspiration catheter as a fishing line to pull the clot back through the balloon catheter and out of the body. Another option, which is not feasible, is to reverse the aspiration to pressurize the clot and forcefully and uncontrollably expel it from the distal opening of the aspiration catheter. For many reasons, this action is dangerous for the patient, the main reason being that forcefully and uncontrollably expelling the clot may cause the clot to move further distally within the blood vessel where it was initially retained. This distal movement not only causes the clot to be further distally in the blood vessel (i.e., smaller in diameter compared to when it was initially retained), but it also permanently lodges the clot in the blood vessel, making it impossible to remove, or it may cause the blood vessel to rupture. Those skilled in the art know that these situations should be avoided due to the serious potential risks to the patient.

[0005] Even if the surgeon uses the aspiration catheter to fish out the blood clot, it is not guaranteed that all of the clot will be removed. Clot fragments may suddenly stop during movement, and when this occurs, the fragments may re-embolize within the same blood vessel or in different blood vessels, which may be even more difficult to remove.

[0006] When all or most of the clot is aspirated from the patient, it is difficult to confirm whether the entire thrombus has been removed. A significant drawback of current thrombus removal devices is that the surgeon cannot determine the capture / removal of the thrombus without completely withdrawing the given treatment device from the patient's anatomy. Even a system that can completely aspirate a given thrombus is problematic because in the operating room environment, the container in which the aspirated contents are deposited is located outside the sterile area. This location outside the sterile area makes it difficult or impossible for the physician operating the aspiration catheter to easily visualize and evaluate the aspirated thrombus material.

[0007] To confirm thrombus removal may require the surgeon to attempt aspiration again. The aspiration catheter and the balloon guiding catheter must be cleaned, the distal anatomical passage must be re-established, and when the aspiration catheter is finally repositioned at the embolism site, any residual embolization material may present the same problem again. The drawbacks of these procedures are a significant increase in the surgical time, which not only significantly increases the cost (since every minute in the operating room is expensive), but also increases the stress on the surgeon, thereby reducing the success rate of the surgery.

[0008] The first-pass recanalization rate is an indicator used to determine the efficacy of a thrombus removal system. Most current systems provide a rate between 30% and 60%. A system that increases the first-pass recanalization rate is valuable and desirable.

[0009] Even when attempting to maintain the vacuum pressure using manual periodic cycling, the prior art systems cannot avoid positive pressure at the distal end of the catheter. The prior art systems cannot respond quickly enough to prevent positive pressure at the distal end of the catheter. When there is positive pressure at the distal end of the lumen, the fluid from inside the lumen flows out of the distal end of the catheter in the distal direction. This is called forward flow. The prior art does not have a fast enough response time to inhibit forward flow. Therefore, forward flow can and does remove thrombus from the distal end and has the potential to further transport the thrombus distally in the vascular system. Such a system cannot guarantee the removal of all forward flow, thereby eliminating the positive pressure at the distal end of the catheter.

[0010] Therefore, there is a need to overcome the problems in the prior art systems, designs, and processes as described above. Summary of the Invention

[0011] The described system, device, and method provide a thrombus aspiration removal system and a method of removing thrombus using the thrombus aspiration removal system, which overcome the above-mentioned disadvantages of the hitherto known devices and methods of this general type, and provide the feature of an increased first-pass recanalization rate by completely pulling out the thrombus, thereby reducing the situation where the thrombus blocks / clogs the aspiration catheter.

[0012] The system, device, and method provide a thrombus aspiration removal system that completely evacuates the clot, so that the clot is no longer dragged out of the vascular system and half-hanging outside the catheter tip. The thrombus aspiration removal system moves the clot evacuated by the vacuum all the way to the proximal end of the vacuum channel and allows the surgeon to confirm the recanalization of the blood vessel where the clot was previously located (e.g., by injecting a contrast agent into the catheter left in place after clot removal), and provides a structure to indicate to the surgeon that the thrombus has been removed and blood flow has been restored.

[0013] The system, device, and method provide a thrombus aspiration removal system that can be combined with a conventional aspiration catheter to significantly increase the efficacy of such a catheter and pump system. The vacuum level is indicated in two different ways here:

[0014] 1) As an absolute pressure level, where "high vacuum" is close to zero absolute pressure. This is the "absolute pressure" way of measuring vacuum. The ideal vacuum would be zero, and atmospheric pressure would be indicated by measuring the height of a mercury column that can be supported by standard atmosphere (760 mm Hg). Therefore, a lower value indicates an increase in the vacuum level relative to the surrounding atmospheric pressure.

[0015] 2) It is possible to indicate the pressure relative to the atmospheric pressure. This method of measuring pressure relative to the standard atmospheric pressure is called "gauge pressure". The most common method of measuring pressure in the vacuum range (below atmospheric pressure) is to use a calibrated gauge such that one atmospheric pressure reads zero (standard atmospheric pressure), and the highest possible vacuum level is expressed as "29.92 inches of mercury". Ordinary mechanical vacuum gauges work in this way, and thus this usage has become common.

[0016] In this document, "gauge pressure" is used as a method of indicating the vacuum level; that is, "zero inches of mercury" refers to the atmospheric pressure and there is no suction at all. A high number (e.g., 25" of mercury) means a high level of vacuum suction. (The highest possible vacuum level measured in this way will be 29.92" Hg). The "vacuum" used in this document is a situation below the normal atmospheric pressure. In this application, the unit of vacuum pressure is pounds per square inch ("PSI", "psi"), inches of mercury or mmHg. Depending on the context in which the term "vacuum" is used, "high" vacuum is referred to as a low pressure below the atmospheric pressure in this document. Vacuum also refers to negative pressure, and pressure above the atmospheric pressure is called positive pressure. However, in some cases, based on the context, using the term "high" for pressure may mean a greater negative pressure or may also mean a greater positive pressure. Similarly, based on the context, using the term "low" or "lower" for pressure can mean a smaller negative pressure or can also mean a smaller positive pressure.

[0017] The diameter of a thrombus is usually larger than the diameter of the catheter used to aspirate the thrombus. For aspiration to be successful, the thrombus must deform to conform to the inner diameter of the aspiration catheter. During conventional aspiration, applying vacuum usually sucks part of the thrombus into the distal opening of the aspiration catheter lumen. At this time, the thrombus gets stuck, with some of the thrombus remaining within the catheter inner diameter and some protruding distally.

[0018] These systems, devices, and methods provide a thrombus aspiration and removal system with a patent structure, and a technique of being able to temporarily stop the vacuum at the distal end of the aspiration catheter, push the thrombus distally out of the lumen, and then re - apply the vacuum - an occlusion - vacuum - pressure operation sequence. After re - applying the vacuum, the thrombus accelerates back into the catheter and deforms to a diameter such that it can be completely aspirated. Each time the vacuum is stopped, the thrombus is pushed, and the vacuum is re - applied is controlled by the surgeon.

[0019] The system and method use a mechanism to stop the vacuum to operate a suction / inhalation catheter, and then reversely press the distal liquid column, i.e., positive displacement without a check valve, herein referred to as column displacement. All functions can be controlled by one handle, including vacuum shut-off and column displacement, while limiting the amount and force of column displacement. When the controller is actuated, a positive outlet flow is generated without the possibility of overshoot. The outflow movement of the fluid is restricted to a specific volume and / or pressure and is automatically and precisely controlled. It is the user who controls when column displacement occurs and when the column returns. A trap is provided at the outlet to capture and display thrombi. Venting can be opened to the atmosphere to clear the fluid in the trap and show how much thrombus remains.

[0020] In view of the foregoing and other purposes, there is provided a vacuum catheter for removing an object from a human blood vessel, the vacuum catheter including a vacuum tube defining an internal vacuum channel and a vacuum interruption controller, the vacuum channel including a proximal opening for receiving a vacuum application and a distal capture opening fluidly connected to the proximal opening, the distal capture opening being configured to receive an object therein in response to the vacuum application, and the vacuum channel including an intermediate portion between the proximal opening and the distal capture opening, and the vacuum interruption controller including a body and an extrusion compressor, a portion of the intermediate portion passing through the body, the extrusion compressor being movably arranged relative to the body toward and away from the portion of the intermediate portion such that in a stationary state, the extrusion compressor does not block the vacuum channel, and in an actuated state, the extrusion compressor first blocks the vacuum channel and then moves the fluid disposed between the portion of the intermediate portion and the distal capture opening distally toward the distal capture opening a given distance.

[0021] According to another feature, there is provided a vacuum pump for selectively applying a vacuum to the proximal opening.

[0022] According to yet another feature, the vacuum tube has a proximal portion and further includes a catheter body surrounding the vacuum tube and configured to guide at least the proximal portion of the vacuum tube.

[0023] According to an additional feature, the vacuum tube has a proximal portion sized to fit within the Circle of Willis in the brain, and the object is a blood clot adjacent to the Circle of Willis.

[0024] In view of the foregoing and other purposes, there is provided a clot removal system that includes: a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion; a controllable vacuum valve; a vacuum source fluidly connected to the vacuum valve; a controllable exhaust valve having an exhaust liquid inlet; an exhaust fluid source containing exhaust liquid and fluidly connected to the exhaust valve to hold the exhaust liquid at the exhaust liquid inlet; a manifold connected to the catheter, to the vacuum valve, and to the exhaust valve, the manifold fluidly connecting the proximal portion of the liquid column in the lumen to the vacuum source through the vacuum valve and to the exhaust fluid source through the exhaust valve; and a controller connected to the vacuum valve and the exhaust valve and configured to selectively open and close the vacuum valve and the exhaust valve such that in response to opening the vacuum valve, the vacuum source is fluidly connected to the liquid column in the lumen, and in response to opening the exhaust valve, the exhaust fluid source is fluidly connected to the liquid column in the lumen, the controller being configured to cyclically open and close the vacuum valve and the exhaust valve to vary the vacuum level at the distal end during each cycle and prevent forward flow of the distal portion from the distal end.

[0025] In view of these purposes, there is also provided a clot removal system that includes: a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion; a controllable vacuum valve; a vacuum source fluidly connected to the vacuum valve; a controllable exhaust valve having an exhaust liquid inlet; an exhaust fluid source containing exhaust liquid and fluidly connected to the exhaust valve to hold the exhaust liquid at the exhaust liquid inlet; a manifold connected to the catheter, to the vacuum valve, and to the exhaust valve, the manifold fluidly connecting the proximal portion of the liquid column in the lumen to the vacuum source through the exhaust valve and to the exhaust fluid source through the exhaust valve; and a controller connected to the vacuum valve and the exhaust valve and configured to selectively open and close the vacuum valve and the exhaust valve such that in response to opening the vacuum valve, the vacuum source is fluidly connected to the liquid column in the lumen, and in response to opening the exhaust valve, the exhaust fluid source is fluidly connected to the liquid column in the lumen, the controller being configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle that includes a double-closed state in which the vacuum valve is closed and the exhaust valve is closed to vary the vacuum level at the distal end during each cycle and prevent forward flow of the distal portion from the distal end, the time of the double-closed state being no greater than about 30 ms.

[0026] In view of these purposes, there is also provided a clot removal system that includes: a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion; a vacuum source; an exhaust liquid source; and a vacuum and exhaust control system configured to cyclically connect or disconnect the vacuum source and the exhaust liquid source to vary the vacuum level at the distal end and substantially prevent forward flow.

[0027] For these purposes, there is also provided a clot removal system that includes: a catheter having a distal end and defining a lumen filled with a column of liquid having a proximal portion and a distal portion; a vacuum source; an exhaust liquid source; and a vacuum and exhaust control system configured to cyclically fluidly connect at least one of vacuum from the vacuum source, exhaust liquid from the exhaust liquid source, and neither vacuum nor exhaust liquid to the proximal portion to thereby vary the vacuum level at the distal end and substantially prevent forward flow.

[0028] According to another feature, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle that includes a dual-closed state in which the vacuum valve is closed and the exhaust valve is closed.

[0029] According to yet another feature, the time of the dual-closed state is no greater than 30 ms.

[0030] According to an additional feature, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle that includes an only-exhaust state in which the vacuum valve is closed and the exhaust valve is open.

[0031] According to an additional feature, the time of the only-exhaust state is no greater than 50 ms.

[0032] According to yet another feature, the controller is configured to selectively open and close the vacuum valve and the exhaust valve in a repeating cycle that includes an only-vacuum state in which the vacuum valve is open and the exhaust valve is closed, a first dual-closed state in which the vacuum valve is closed and the exhaust valve is closed, an only-exhaust state in which the vacuum valve is closed and the exhaust valve is open, and a second dual-closed state in which the vacuum valve is closed and the exhaust valve is closed.

[0033] According to yet another feature, the time between when the exhaust valve opens and when the exhaust valve closes is between about 10 ms and about 50 ms.

[0034] According to yet an additional feature, the period of the cycle is between about 6 Hz and about 16 Hz.

[0035] According to another additional feature, the period of the cycle is between about 8 Hz and 12 Hz.

[0036] Again according to another feature, the change in the vacuum level at the distal end is greater than about 15 inHg in no greater than about 50 ms.

[0037] Again according to another feature, the change in the vacuum level at the distal end is greater than about 20 inHg and no greater than about 30 ms; and

[0038] Again according to another feature, the change in the vacuum level at the distal end is greater than about 25 inHg and no greater than about 20 ms.

[0039] Again, according to an additional feature, the inner diameter of the lumen is between approximately 0.038” and approximately 0.106”, and the controller is configured to cyclically open and close the vacuum valve and the exhaust valve at a frequency of 2 to 16 Hz.

[0040] Again, according to another feature, the inner diameter of the lumen is between approximately 0.068” and approximately 0.088”, and the controller is configured to cyclically open and close the vacuum valve and the exhaust valve at a frequency between 2 and 16 Hz.

[0041] According to yet another feature, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle and prevent forward outflow from the distal portion at each cycle by adjusting the timing of the exhaust valve.

[0042] According to yet another feature, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve to maintain the pressure level at the distal end at less than physiological pressure.

[0043] According to an accompanying feature, a shaft is provided on which the vacuum valve and the exhaust valve are mounted together.

[0044] The operation of the ROAR process described and shown below is successful in removing blood clots for two reasons. First, the ROAR effect overcomes the static friction of the clot that is fixed or “stuck” at the catheter tip under constant suction. The ROAR process provides an oscillatory / alternating displacement that shuttles the clot back and forth to overcome the static friction. Second, there is fragmentation of the clot, overcoming different clot morphologies and overcoming the volume and diameter constraints of the small and fixed lumen volume determined by the microanatomical environment.

[0045] The systems and methods described and shown herein respond fast enough to prevent the pressure at the distal end from becoming positive. By cycling the vacuum valve and the exhaust valve at a fast enough rate, pressure measurements are taken at the distal end of the catheter lumen at a rate of one thousand samples per segment, demonstrating that the distal end of the ROAR catheter does not experience positive pressure and substantially eliminates forward flow. The time between operating the vacuum valve and the exhaust valve can be adjusted such that physical mechanisms that would cause positive pressure at the distal end can be avoided in both the open flow state and the occluded state.

[0046] According to an exemplary embodiment, the distal portion of the liquid column exiting the distal end is restricted to no more than approximately 2 microliters.

[0047] According to an exemplary embodiment, a clot removal system includes: a catheter having a distal end and defining a lumen filled with a column of fluid, the column of fluid having a proximal portion and a distal portion; a vacuum source; an exhaust fluid source including an exhaust liquid; and a vacuum and exhaust control system configured to cyclically fluidly connect at least one of a vacuum from the vacuum source and an exhaust fluid from the exhaust fluid source to the proximal portion and disconnect from the proximal portion, thereby changing the vacuum level at the distal end and substantially preventing the distal portion of the column of fluid from leaving the distal end.

[0048] According to an exemplary embodiment, a clot removal system includes: a catheter having a distal end and defining a lumen filled with a column of fluid, the column of fluid having a proximal portion; and a vacuum and exhaust control system configured to cyclically connect and disconnect a vacuum and an exhaust fluid to and from the proximal portion to generate a forward flow pressure pulse therein, thereby generating a reverse flow in the column of fluid and substantially preventing the forward flow pressure pulse from reaching the distal end.

[0049] According to an exemplary embodiment, a clot removal system includes: a catheter having a distal end and defining a lumen filled with a column of fluid, the column of fluid having a proximal portion; and a vacuum and exhaust control system configured to cyclically connect and disconnect a vacuum and an exhaust fluid to and from the proximal portion to generate a forward flow pressure pulse therein, and to generate a reverse flow in the column of fluid before the forward flow pressure pulse reaches the distal end, thereby substantially preventing the forward flow pressure pulse from reaching the distal end.

[0050] According to an exemplary embodiment, a clot removal system includes: a catheter having a distal end and defining a lumen filled with a column of fluid, the column of fluid having a proximal portion; and a vacuum and exhaust control system configured to cyclically connect and disconnect a vacuum and an exhaust fluid to and from the proximal portion to allow the column of fluid to move and stop to generate a forward flow pressure pulse therein, and to alternately control to generate a reverse flow in the column of fluid before the forward flow pressure pulse reaches the distal end, thereby controlling the forward flow pressure pulse by substantially preventing the forward flow pressure pulse from reaching the distal end.

[0051] According to an exemplary embodiment, the controller is configured to change the vacuum level at the distal end in a cycle while preventing a certain distance distally of the distal portion of the column of fluid.

[0052] According to an exemplary embodiment, the controller is configured to selectively open and close a vacuum valve and an exhaust valve in a repeating cycle that includes: a first state in which the vacuum valve is open and the exhaust valve is closed; a second state in which the vacuum valve is closed and the exhaust valve is closed; a third state in which the vacuum valve is closed and the exhaust valve is open; and a fourth state in which the vacuum valve is closed and the exhaust valve is closed.

[0053] According to an exemplary embodiment, a clot removal system includes: a catheter defining a lumen filled with a column of fluid from a proximal portion to a distal end; and a water hammer controller configured to alternately connect a vacuum and / or a fluid at atmospheric pressure or body pressure or lower pressure to the lumen, thereby causing the column of fluid to move and stop to form a water hammer therein, and before the water hammer reaches the distal end, perform an alternate control to generate a reverse flow, thereby controlling the water hammer by substantially preventing the water hammer from reaching the distal end.

[0054] According to an exemplary embodiment, a clot removal system includes: a catheter having a lumen, a vacuum source, a controllable vacuum valve, an exhaust fluid source, a controllable exhaust valve, a manifold connected to the catheter, to the vacuum valve, and to the exhaust valve, and a controller for controlling the vacuum valve and the exhaust valve.

[0055] According to an exemplary embodiment, the controller is configured to regulate the vacuum valve and the exhaust valve in a cycle such that in response to a vacuum applied to the catheter, the compliance of the catheter causes a volume reduction such that when the vacuum valve is closed and the exhaust valve is open, the compliance acts as a spring and the lumen absorbs the exhaust liquid in the distal direction, and before the momentum caused by the absorbed liquid reaches the distal end of the catheter, the controller adjusts the valves to reverse the direction of fluid flow and eliminate the movement of the fluid, and prevent the fluid from flowing out of the distal end of the catheter.

[0056] According to an exemplary embodiment, a clot removal system includes: a catheter having a lumen; a substantially incompressible connecting tube having an internal lumen, the connecting tube having a proximal end and a distal end fluidly connected to the lumen; a vacuum source; and a vacuum / exhaust manifold including a manifold chamber having an outlet fluidly connected to the proximal end, a vacuum line fluidly connected to the manifold and the vacuum source to provide a vacuum from the source to the manifold chamber, and an exhaust line fluidly connected to the manifold and a liquid bath at atmospheric pressure.

[0057] According to an exemplary embodiment, a clot removal system includes a fixed cycle having a plurality of pinch valves and a plurality of cams, the plurality of cams being mechanically coupled to the valves such that the direction of the cams cannot be changed.

[0058] According to an exemplary embodiment, the time for eliminating the forward flow pulse is not greater than about 20 ms.

[0059] According to an exemplary embodiment, a clot removal system includes a pulsatile vacuum controller configured to alternately connect a vacuum and / or a fluid at atmospheric pressure / body pressure / slightly below body pressure / slightly above body pressure to a chamber, allowing a liquid column to move and stop to generate a forward flow pressure pulse therein, and (alternately controlling to generate a reverse flow before the forward flow pressure pulse reaches the distal end, so as to) control the forward flow pressure pulse by substantially preventing the forward flow pressure pulse from reaching the distal end.

[0060] Although the systems, devices, and methods shown and described herein are embodied in an aspiration thrombectomy system and method for using an aspiration catheter to remove blood clots, they are not intended to be limited to the details shown, as various modifications and structural changes may be made without departing from the spirit of the invention and within the scope and range of equivalents of the claims. Additionally, well-known elements of the exemplary embodiments will not be described in detail or will be omitted so as not to obscure the relevant details of the systems, devices, and methods.

[0061] Additional advantages and other characteristics of the systems, devices, and methods will be set forth in the following detailed description and will become apparent from the detailed description, or may be learned by practice of the exemplary embodiments. Other advantages of the systems, devices, and methods may be realized by any means, methods, or combinations particularly pointed out in the claims.

[0062] Other features that are regarded as characteristics of the systems, devices, and methods are set forth in the appended claims. As needed, detailed embodiments of the systems, devices, and methods are disclosed herein. However, it should be understood that the disclosed embodiments are merely examples of the systems, devices, and methods that may be presented in various forms. Thus, the specific structural and functional details disclosed herein should not be construed as restrictive, but merely as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art to employ the systems, devices, and methods of the present invention in almost any appropriate detailed structure differently. Additionally, the terms and phrases used herein are not intended to be restrictive; rather, they provide an understandable description of the systems, devices, and methods. Although the specification concludes with claims that define the systems, devices, and methods of the present invention that are regarded as novel, it is believed that the systems, devices, and methods will be better understood by considering the following description in conjunction with the drawings. The same reference numerals continue to be used in the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] In the accompanying drawings, like reference numerals in all the separate views refer to the same or functionally similar elements. These separate views are not drawn to scale and are incorporated into the specification and form a part of the specification together with the following detailed description. These drawings are used to further illustrate various embodiments and to explain various principles and advantages, all of which are based on systems, devices, and methods. The advantages of the embodiments of the systems, devices, and methods will be apparent from the following detailed description of the exemplary embodiments, which description should be considered in conjunction with the accompanying drawings, in which:

[0064] Figure 1 is a partial perspective view of an exemplary embodiment of a controller for a thrombectomy aspiration catheter in an unactuated state;

[0065] Figure 2 is Figure 1 a partial perspective longitudinal cross-sectional view of the controller;

[0066] Figure 3 is Figure 1 an enlarged schematic side elevational view of the compression cam assembly of the controller;

[0067] Figure 4 is Figure 1 a partial longitudinal cross-sectional view of the controller with the compression roller removed;

[0068] Figure 5 is Figure 1 a partial longitudinal cross-sectional view of the controller in an actuated state;

[0069] Figure 6 is Figure 1 a partial enlarged perspective view of a portion of the extrusion compressor of the controller;

[0070] Figure 7 is Figure 1 a partial perspective view of the controller in an actuated state;

[0071] Figure 8 is Figure 7 a partial perspective, partial longitudinal cross-sectional view of the controller;

[0072] Figure 9 is Figure 8 a partial perspective longitudinal cross-sectional view of the controller in an intermediate actuated state, in which the compression roller blocks the aspiration catheter and rolls partially to cause displacement of the liquid column;

[0073] Figure 10 is Figure 9 a partial longitudinal cross-sectional view of the controller;

[0074] Figure 11 is Figure 1Partial perspective longitudinal cross-sectional view of the controller, where the compression roller blocks the suction catheter and rolls completely to cause the movement of the liquid column;

[0075] Figure 12 is Figure 11 Partial longitudinal cross-sectional view of the controller;

[0076] Figure 13 is Figure 9 Longitudinal cross-sectional view of the controller, where the compression roller and the suction catheter are removed.

[0077] Figure 14 is a partial perspective longitudinal cross-sectional view of the controller in an unactuated state and schematically connected to the distal portion of the suction catheter, where a thrombus remains in the distal opening of the vacuum channel; Figure 1

[0078] Figure 15 Figure 12 is Partial perspective longitudinal cross-sectional view of the controller in an actuated state, where the column displacement expels the thrombus distally from the distal opening of the vacuum channel;

[0079] Figure 16 Figure 1 is Partially enlarged perspective longitudinal cross-sectional view of the distal portion of the controller and an exemplary embodiment of the vacuum booster, which is provided between the controller and the distal range of the suction catheter, where the vacuum booster is in an energized state;

[0080] Figure 17 Figure 16 is Partially enlarged perspective longitudinal cross-sectional view of the controller and the vacuum booster, where the vacuum booster is in a relaxed state;

[0081] Figure 18 Figure 1 is Partially enlarged perspective, partially transparent view of the proximal portion of the controller and an exemplary embodiment of the thrombus trap;

[0082] Figure 19 Figure 18 is Partially enlarged perspective view of the controller and the thrombus trap, where the intermediate housing of the thrombus trap is removed;

[0083] Figure 20 Figure 18 is Partially enlarged perspective view of the controller and the thrombus trap;

[0084] Figure 21 Figure 16 is Figure 18 of the controller and Partial perspective longitudinal cross-sectional view of the thrombus trap;

[0085] Figure 22 ​Partial longitudinal sectional view of an exemplary embodiment of a volume change controller;

[0086] Figure 23 Vacuum circuit diagram of an exemplary embodiment of a vacuum booster and a vacuum booster control device;

[0087] Figure 24 Cyclic flowchart of the operation of an exemplary embodiment of a controller with a vacuum booster and a thrombus trap;

[0088] Figure 25 Perspective view of an automatic thrombus aspiration and removal system, which is to be connected distally to an aspiration catheter, proximally to a vacuum and exhaust line, and the cam housing is removed;

[0089] Figure 26 Is Figure 25 Partial top view of the thrombus aspiration and removal system, in which the aspiration catheter and the vacuum line and exhaust line are schematically shown;

[0090] Figure 27 Is Figure 25 Front view of the proximal side of the thrombus aspiration and removal system;

[0091] Figure 28 Is Figure 25 Front view of the bearing side of the thrombus aspiration and removal system;

[0092] Figure 29 Is Figure 25 Perspective longitudinal sectional view of the thrombus aspiration and removal system, in which the vacuum valve is in the closed state, the exhaust valve is in the open state, and the indicator of the position reset assembly is in the zero reset state;

[0093] Figure 30 Is Figure 29 Longitudinal sectional view of the thrombus aspiration and removal system;

[0094] Figure 31 Is Figure 25 Enlarged sectional view of the valve and cam group of the thrombus aspiration and removal system, in which the cam is in the rotating position to set the valve to the intermediate closed position;

[0095] Figure 32 Is Figure 31 Enlarged sectional view of the valve and cam group, in which the cam is in the rotating position to close the valve;

[0096] Figure 33 Is along Figure 30 The sectional line 33-33 of Figure 25 Sectional view of the thrombus aspiration and removal system, in which the cam housing is removed;

[0097] Figure 34 IsFigure 25 Perspective view of a thrombectomy aspiration system, with the motor assembly housing removed;

[0098] Figure 35 is Figure 26 Top view of a thrombectomy aspiration system, with the motor assembly housing removed;

[0099] Figure 36 is Figure 27 Front view of a thrombectomy aspiration system, with the motor assembly housing removed;

[0100] Figure 37 is Figure 28 Front view of the bearing side of a thrombectomy aspiration system, with the motor assembly housing removed;

[0101] Figure 38 is a Figure 25 Perspective view of a thrombectomy aspiration system with a cam housing;

[0102] Figure 39 is a Figure 26 Top view of a thrombectomy aspiration system with a cam housing;

[0103] Figure 40 is a Figure 27 Front view of a thrombectomy aspiration system with a cam housing;

[0104] Figure 41 is a Figure 28 Front view of the bearing side of a thrombectomy aspiration system with a cam housing;

[0105] Figure 42 Partial perspective view of an exemplary embodiment of a rotational pintle valve to be used with a thrombectomy aspiration system in a first valve state;

[0106] Figure 43 is Figure 42 Partial cross-sectional view of the valve;

[0107] Figure 44 is Figure 42 Partially hidden perspective view of the valve;

[0108] Figure 45 is Figure 42 Partially hidden perspective view of the valve in a second valve state;

[0109] Figure 46 is Figure 45 Partial cross-sectional view of the valve;

[0110] Figure 47Is a schematic cross-sectional view of an exemplary embodiment of a thrombectomy aspiration system;

[0111] Figure 48 Is for operating using the ROAR process with damped pressure pulses Figure 47 Of a graph of an exemplary embodiment of the waveform of the system;

[0112] Figure 49 Is a diagram showing Figure 47 Of an exemplary embodiment of one cycle of the waveform operation of the vacuum valve and exhaust valve of the system;

[0113] Figure 50 Is a diagram showing at Figure 49 Of the waveform operation of Figure 47 Of the pressure curves at the proximal and distal portions of the lumen of the catheter of the system;

[0114] Figure 51 Is a diagram showing combined in time Figure 49 And 50 Of the waveforms;

[0115] Figure 52 Is for operating using the ROAR process with damped pressure pulses Figure 47 Of a graph of an exemplary embodiment of the waveform of the system;

[0116] Figure 53 Is a diagram showing Figure 47 Of the vacuum valve and exhaust valve positions for tuning the valve to produce the ROAR effect of the system;

[0117] Figure 54 Is for Figure 47 Of a partial longitudinal cross-sectional view of the proximal manifold connector assembly of the system;

[0118] Figure 55 Is a block diagram of an exemplary embodiment of a self - contained thrombectomy aspiration system;

[0119] Figure 56 Is of a block diagram of the system of an exemplary embodiment of a proximal manifold connector assembly having a remote control Figure 55 ;

[0120] Figure 57 Is a perspective view of an exemplary embodiment of a self - contained thrombectomy aspiration system having a collection tank and an exhaust liquid reservoir with schematic indications;

[0121] Figure 58 Is Figure 57 Of a partial perspective view of the cartridge connection assembly of the system;

[0122] Figure 59 Is Figure 57 Of a top view of the system;

[0123] Figure 60 is Figure 57 a left side view of the system;

[0124] Figure 61 is Figure 57 a right side view of the system;

[0125] Figure 62 is a perspective view of an exemplary embodiment of a self - contained thrombus aspiration and removal system, in which a collection canister and a suspended exhaust liquid reservoir are schematically shown;

[0126] Figure 63 is Figure 62 a left side view of the system;

[0127] Figure 64 is Figure 62 a right side view of the system;

[0128] Figure 65 is Figure 62 a top view of the system;

[0129] Figure 66 is Figure 57 a front view of the system;

[0130] Figure 67 is Figure 57 a partial front perspective view of the cassette connection assembly and the suspended exhaust liquid reservoir of the system;

[0131] Figure 68 is Figures 57 to 67 a top view of an exemplary embodiment of the valve cassette of the system, in which the fluid chamber pipeline view is hidden;

[0132] Figure 69 is Figure 69 a bottom plan view of the valve cassette;

[0133] Figure 70 is Figure 69 a bottom perspective view of the valve cassette;

[0134] Figure 71 is Figure 69 a bottom perspective view of the valve cassette; and

[0135] Figure 72 is a schematic diagram of an exemplary embodiment of a self - contained thrombus aspiration and removal system. Detailed Description of the Invention

[0136] As needed, detailed embodiments of systems, apparatuses, and methods are disclosed herein; however, it should be understood that the disclosed embodiments are merely examples of systems, apparatuses, and methods that may be presented in various forms. Accordingly, the specific structural and functional details disclosed herein should not be construed as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to use the systems, apparatuses, and methods in a variety of manners under almost any appropriate detailed structure. Additionally, the terms and phrases used herein are not intended to be limiting; rather, they provide an understandable description of the systems, apparatuses, and methods. Although the specification concludes with claims that define the features of the systems, apparatuses, and methods that are considered novel, it is believed that the systems, apparatuses, and methods may be better understood by considering the following description in conjunction with the accompanying drawings, in which like reference numerals continue to be used.

[0137] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration embodiments that may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope. Accordingly, the following detailed description is not to be considered limiting, and the scope of the embodiments is defined by the appended claims and their equivalents.

[0138] Alternative embodiments may be devised without departing from the spirit or scope of the present invention. Additionally, well-known elements of exemplary embodiments of the systems, apparatuses, and methods will not be described in detail or will be omitted so as not to obscure the relevant details of the systems, apparatuses, and methods.

[0139] Before disclosing and describing the systems, apparatuses, and methods, it should be understood that the terms used herein are for the purpose of describing particular embodiments only and are not limiting. The term "comprising", "including", or any other variant thereof is intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element preceded by "comprising... a" does not exclude the presence of other like elements in the process, method, article, or apparatus that comprises the element. The terms "comprising" and / or "having" as used herein are defined to include (i.e., open language). As used herein, the term "a" is defined as one or more than one. The term "plural" as used herein is defined as two or more than two. As used herein, the term "another" is defined as at least second or more. The description may use the term "one or more embodiments", which may refer to one or more of the same or different embodiments respectively.

[0140] The terms "coupled" and "connected" and their derivatives may be used. It should be understood that these terms are not intended to be synonymous with each other. Rather, in a particular embodiment, "connected" may be used to indicate that two or more elements are in direct physical or electrical contact with each other. "Coupled" may mean that two or more elements are in direct physical or electrical contact (e.g., directly coupled). However, "coupled" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other (e.g., indirectly coupled).

[0141] For purposes of illustration, a phrase in the form of "A / B" or "A and / or B" or "at least one of A and B" means (A), (B), or (A and B), where A and B are variables representing particular objects or attributes. When used, this phrase is intended and thereby defined as the choice of A or B or both A and B, similar to the phrase "and / or". In the case where there are more than two variables in this phrase, this phrase is herein defined to include only one variable, any one variable, any combination of any variables, and all variables, e.g., a phrase in the form of "at least one of A, B, and C" means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C).

[0142] Relational terms such as first and second, top and bottom, etc. may be used solely to distinguish one entity or action from another entity or action, and do not necessarily require or imply any actual such relationship or order between such entities or actions. The description may use perspective-based descriptions, such as up / down, back / front, top / bottom, and proximal / distal. Such descriptions are only used to facilitate discussion and are not intended to limit the application of the disclosed embodiments. Various operations may be described as multiple discrete operations in a manner that aids in understanding the embodiments; however, the order of the description should not be construed as implying that these operations are order-dependent.

[0143] As used herein, the terms "about" or "approximately" apply to all numerical values, whether or not explicitly stated. These terms generally refer to a range of numbers that a person of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, these terms may include numbers that round to the nearest significant digit. As used herein, the terms "substantially" and "substantially" mean that when comparing various parts to each other, the parts being compared are equal in size or close enough that a person of ordinary skill in the art would consider them the same. As used herein, substantially and substantially are not limited to a single dimension and specifically include a range of values for the parts being compared. The range of values above and below (e.g., "+ / -" or more / or less or greater / smaller) includes variations within the reasonable tolerances for the component that a person of ordinary skill in the art would know.

[0144] It will be understood that embodiments of the systems, apparatuses, and methods described herein can consist of one or more conventional processors and unique stored program instructions that control one or more processors to implement some, most, or all of the functions of the systems, apparatuses, and methods described herein in conjunction with certain non-processor circuits and other elements. The non-processor circuits can include, but are not limited to: signal drivers, clock circuits, power supply circuits, and user input and output elements. Optionally, some or all of the functions can be implemented by a state machine without stored program instructions, or in one or more application specific integrated circuits (ASICs) or field programmable gate arrays (FPGAs), where each function or a combination of certain functions is implemented as custom logic. Of course, combinations of these methods can also be used. Thus, methods and apparatuses for these functions have been described herein.

[0145] As used herein, the terms "program", "software", "software application", etc. are defined as a series of instructions designed to be executed on a computer system or programmable device. A "program", "software", "application", "computer program", or "software application" can include subroutines, functions, procedures, object methods, object implementations, executable applications, applets, mini-applications, source code, object code, any computer language logic, shared libraries / dynamic load libraries, and / or other sequences of instructions designed to be executed on a computer system.

[0146] Various embodiments of systems, apparatuses, and methods are described herein. In many different embodiments, the features are similar. Therefore, to avoid redundancy, in some cases these similar functions may not be described repeatedly. However, it should be understood that the description of the features at the first occurrence applies to the similar features described later, and thus, each corresponding description will be incorporated therein without such repetition.

[0147] Exemplary embodiments are now described. Now referring in detail and first to the drawings, particularly Figures 1 to 13 , a first exemplary embodiment of a single-handed controller 10 of a thrombectomy system 1 utilizing a vacuum tube 2 is shown. The controller 10 includes a first handle portion 20 and a second handle portion 40. The first handle portion 20 is connected to and holds the vacuum tube 2, and thus is also referred to as the handle base. The second handle portion 40 moves relative to the first handle portion 20, and thus, the second handle portion 40 is also referred to as the compressor-actuator 40.

[0148] In one exemplary embodiment, the first handle portion 20 has a distal tube anchor 22 and a proximal tube anchor 24. In this embodiment, the distal tube anchor 22 and the proximal tube anchor 24 are in the form of hollow tubes through which the vacuum tube 2 passes. The distal tube anchor 22 and the proximal tube anchor 24 hold the vacuum tube 2 in the hollow tube without substantially compressing the vacuum tube 2 (and thus without reducing or closing the internal vacuum passage 3). The vacuum tube 2 can be made of many materials, including: latex, silicone, polyurethane, polyvinyl chloride or other synthetic rubbers. An exemplary size of the vacuum tube 2 has an inner diameter (I.D.) of about 0.055 to 0.095 inches. An exemplary embodiment for holding the vacuum tube 2 is an adhesive that bonds the material of the vacuum tube 2 to the inner lumen of the tubular tube anchors 22, 24. In this exemplary embodiment, the vacuum tube 2 is fixed to the first handle portion 20. In an alternative embodiment, the first handle portion 20 is a flip-top having two first handle portion halves (not shown) that open to receive the cylindrical vacuum tube 2, and when closed, the tube anchors 22, 24 tightly grip the vacuum tube 2 therein without substantially closing or blocking the vacuum passage 3 of the vacuum tube 2. In an exemplary flip-top embodiment, the first handle portion 20 is Figure 2 horizontally separated by a hinge at the dashed line in the figure, allowing a portion of the vacuum tube 2 to be inserted into or removed from the distal tube anchor 22 and the proximal tube anchor 24. A lock secures the vacuum tube 2 therein until the user desires to remove it. The hinge can be used to allow the surgeon to reposition the controller 10 along the vacuum tube 2.

[0149] Exemplary embodiments of the distal tube anchor 22 and the proximal tube anchor 24 are spaced apart from each other. Between the distal tube anchor 22 and the proximal tube anchor 24 of the first handle portion 20 is a compression base plate 26. When installed within the first handle portion 20, the vacuum tube 2 is placed against the compression base plate 26 between the distal tube anchor 22 and the proximal tube anchor 24 without substantially closing or blocking the vacuum passage 3. Figure 13 The compression base plate 26 of the first handle portion 20 is shown with the vacuum tube 2 removed.

[0150] The first handle portion 20 has a hollow interior that defines a set of parallel sidewalls 32 on either side of the vacuum tube 2. The first handle portion 20 includes a compression cam assembly 30 that allows the second handle portion 40 to move in two directions relative to the first handle portion 20. More specifically, in the exemplary embodiment, the compression cam assembly 30 includes a set of slots 34 formed in the sidewalls 32 of the first handle portion 20. As Figure 3As shown in the enlarged view, these slots 34 have a vertical extent 35 and an inclined extent 36. The vertical extent 35 has a vertical length, and the inclined extent 36 has a vector length composed of a second vertical extent 37 and a horizontal extent 39. Accordingly, as described below, the slots 34 provide a cam surface for causing the second handle portion 40 to move in the same shape as the slots 34.

[0151] In an exemplary embodiment, in order to bring the first handle portion 20 and the second handle portion 40 into contact with each other, the second handle portion 40 has a hollow interior into which the first handle portion 20 is inserted and protrudes. (In an alternative embodiment, the first handle portion 20 has a hollow interior into which the second handle portion 40 is inserted and protrudes.) The width between the inward-facing side surfaces of the hollow compartment of the second handle portion 40 is approximately equal to the width of the outer surface of the side wall 32, such that the second handle portion 40 can move up and down closely but smoothly on the first handle portion 20 with little or no frictional force. In contrast, the length between the inward-facing longitudinal surfaces of the hollow compartment of the second handle portion 40 is greater than the length of the outer surface of the longitudinal wall 38. The difference in length is long enough to allow the second handle portion 40 to move along the horizontal extent 39 that is longitudinally parallel to the vacuum tube 2 within the entire horizontal extent 39.

[0152] By providing the compressor-actuator 40 with bosses 42 that protrude from the interior of the hollow compartment of the compressor-actuator 40 facing the side wall 42, the movement of the compressor-actuator 40 relative to the handle base 20 follows the slots 34; one circular boss 42 is associated with each slot 34. In this way, the movement of the compressor-actuator 40 is guided and restricted by the shape of the slots 34. In Figure 1 、 2 and in the unactuated state of the controller 10 shown in 4, the bosses 42 are located at the ends of the vertical extent 35, and in the exemplary embodiment, the bosses 42 are located at the uppermost ends of the slots 34. (Note that Figures 1 to 13 The embodiment shown provides four slots 34 and four bosses 42. This numerical value is merely exemplary. The boss surfaces of the slots 34, the extents 35, 36 of the slots 34, and the cam followers of the bosses 42 can take any form or shape that enables the controller to operate as described herein.) As seen most clearly in Figure 4 the distance A between the interior of the proximal longitudinal wall 38 of the compressor-actuator 40 and the exterior of the proximal side wall of the first handle portion 20 is longer than the horizontal extent 39 (i.e., |A| > |39|). When as Figure 5When the compressor-actuator 40 shown is fully actuated, the boss 42 travels to the opposite (lowest) end of the slot 34. Thus, the compressor-actuator 40 has traveled a vertical distance equal to the vertical movement of the boss 42 within the vertical range 35 and the inclined range 36, and has traveled a horizontal distance equal to the horizontal range 39. In an exemplary embodiment of the first handle portion 20 and the second handle portion 40, the inner surface of the distal longitudinal wall of the compressor-actuator 40 contacts the outer surface of the distal longitudinal wall of the handle base 20, and this contact is indicated by Figure 4 the arrow B in (i.e., |B| = 0). Thus, when the compressor-actuator 40 is fully actuated, the distance by which these two distal longitudinal walls are separated is equal to the horizontal range 39. Similarly, the distance between the outer surface of the proximal longitudinal wall of the handle base 20 and the inner surface of the proximal longitudinal wall of the compressor-actuator 40 is shortened by a length equal to the horizontal range 39 (i.e., (A - |39|)), as Figure 5 shown. Alternatively, a four-bar linkage can be provided to connect 20 and 40 to produce the same motion as the cam slot and the boss.

[0153] It is obvious from the movement of the compressor-actuator 40 following the slot 34 how the extrusion compressor 50 connected to the compressor-actuator 40 operates during this movement. Figure 1 、 2 In the exemplary embodiments of the extrusion compressor 50 in 4 to 13, the extrusion compressor 50 projects downward from the inner surface of the ceiling of the hollow compartment of the compressor-actuator 40 towards the handle base 20. In particular, the extrusion compressor 50 projects downward towards the compression floor 26 of the handle base 20. The extrusion compressor 50 has a base 52 attached to the second handle portion 40. A flexible arm 54 projects from the base 52 and extends towards the compression floor 26. In an exemplary embodiment, the flexible arm 54 is thinner than the base 52. The materials for manufacturing the base 52 and the flexible arm 54 are substantially non-rigid, and thus, in response to the downward movement, a part of the extrusion compressor 50 contacts the compression floor 26 before the entire vertical movement of the compressor-actuator 40 is completed, and the flexible arm 54 flexes. Example materials for the base 52 and the flexible arm 54 include: ABS, polycarbonate and polypropylene, polyurethane or other thermoplastics or thermoplastic elastomers and / or fiber-filled ABS, polycarbonate and At the distal end of the flexible arm 54 is a gear flange 56, which is shaped to hold the compression roller 60 there. The gear flange 56 has a shaft hole, and the shaft 62 of the compression roller 60 is located in the shaft hole. When the compression roller 60 is installed between the inner sides of the gear flange 56, the compression roller 60 is fixed to the gear flange 56 in all directions except for the rotational movement of the compression roller 60 about the rotational axis 64 of the roller 60; in other words, the roller 60 is allowed to rotate about the axis 64.

[0154] Note that the illustrated extrusion compressor 50 is an exemplary embodiment. Different mechanical configurations that perform the same function may be used. For example, the base 52 and the flexible arm 54 may be replaced with a single beam that is hinged to the ceiling of the internal cavity of the compressor-actuator 40 and biased towards the compression base plate 26 with a biasing device (such as a spring), such that Figure 2 the point where the compression roller 60 contacts the vacuum tube 2 as shown is sufficient to hold the vacuum tube 2, but substantially does not reduce the cross-sectional area of the vacuum channel 3.

[0155] The rotation of the roller 60 depends on how the roller 60 moves towards and along the vacuum tube 2. In this regard, the compression roller 60 has an outer contact surface 66 that contacts the vacuum tube 2 in various ways as the compressor-actuator 40 moves towards the handle base 20. As Figure 6 shown, the longitudinal cross-section of the outer surface 66 is approximately nautilus-shaped (alternatively, the shape may be cylindrical). The outer surface 66 has a contact point 67 that contacts the outer surface of the vacuum tube 2 in the unactuated state of the compressor-actuator 40 as Figure 2 shown (the vacuum channel 3 is unblocked and has a substantially open cross-section). As the compressor-actuator 40 is actuated, the compressor-actuator 40 travels along the vertical range 35. This moves the contact point 67 towards the compression floor 26. When the compressor-actuator 40 has traveled along the entire vertical range 35, as Figure 7 and 8 shown, the contact point 67 moves against the vacuum tube 2 to completely block the vacuum channel 3. At the stage where the boss 42 is at the transition point from the vertical range 35 to the inclined range 36, as it moves the contact point 67 as far as possible towards the compression floor 26 in this direction, since the thickness of the vacuum tube 2 prevents the contact point 67 from moving further towards the compression floor 26.

[0156] In the procedure of using the vacuum tube 2 for thrombus removal, the vacuum channel 3 will be filled with fluid, namely blood. When the vacuum channel 3 is completely blocked, the blood filling the vacuum channel 3 from the contact point 67 of the compression roller 60 distally to the distal side of the vacuum channel 3 defines a column of fluid, and the fluid is incompressible. The controller 10 is configured to apply the extrusion compressor 50 and the compression roller 60 to move the column of fluid in the distal direction by a displacement distance 70. An exemplary volume of the displacement distance is from about 0.001 ml to about 1.0 ml, particularly from about 0.1 ml to about 0.5 ml. An exemplary length of the displacement distance 70 is from about 0.5 mm to about 30 mm, particularly from about 0.5 mm to about 15 mm. To achieve such movement, the compressor-actuator 40 moves further in the direction towards the handle base 20, which means that the boss 42 travels along the inclined range 36 and passes through the end of the inclined range 36. Since the contact point 67 has already been as close as possible to the compression floor 26 as it can move in this direction (i.e., when the boss 42 is at the transition point from the vertical range 35 to the inclined range 36), the extrusion compressor 50 has no other way to move except to bend the flexible arm 54 and / or roll the compression roller 60. The contact surface 66 of the compression roller 60 is shaped to roll against the upper surface of the vacuum tube 2 (in the counterclockwise direction in the view of Figure 2 and Figures 8 to 12 ). Figure 9 and Figure 10 show that the rolling of the compression roller 60 starts at a point where the boss 42 is within the inclined range 36 and approximately half of the distance from the distal end of the slot 34. (Note that the limitations of the computer software generating Figures 9 to 12 do not allow showing a true view of how the vacuum tube 2 is compressed as the compression roller 60 rotates. Therefore, these figures show an approximate view of the compression roller 60 rolling on and above the displacement distance 70 of the vacuum tube 2.) The contact point 67 of the compression roller 60 is offset from the axis of rotation 64 towards the contact surface 66. This forms an over center or toggle such that the initial rolling motion of the pressure roller must first force the contact point 67 to cross the center of the axis of rotation 64. In such a configuration, not only does the compression roller 60 roll when the boss 42 of the compressor-actuator 40 starts to travel in the inclined range 37, but there is also a tactile feedback transmitted to the compressor-actuator 40 when the shaft 62 moves slightly forward. When the user senses this feedback, the feedback indicates to the user that the contact surface 66 of the compression roller 60 has rolled onto a part of the vacuum tube 2 and, as it moves along the vacuum tube 2, squeezes that part to translate the column of fluid in the distal direction of the vacuum tube 2. As shown in Figure 11 and 12As shown, as the compressor-actuator 40 moves completely towards the handle base 20, the compression roller 60 has completed its defined rotation above the vacuum tube 2 and, in so doing, has squeezed a section of the vacuum channel 3 from the proximal side to the distal side by a certain length to displace the liquid column distally by a length equal to the displacement distance 70.

[0157] To return the controller 10 to Figure 1 and 2 the initial unactuated state shown, for example, a biasing device 12 is inserted between any surface of the inner hollow of the compression-actuator 40 and any surface of the inner hollow of the handle base 20. In Figure 2 and 8 the exemplary embodiment shown, the biasing device 12 is disposed between the surface of the ceiling within the inner hollow of the compression-actuator 40 and the upper surface of the proximal tube anchor 24. This configuration of the biasing device 12 is merely exemplary, and any return spring or similar mechanical device can be placed and used. When the user releases the pressure on the compression-actuator 40, the flexible arm 54 and / or the biasing device 12 return the compression-actuator 40 to the initial unactuated state. This action causes the compression roller 60 to roll in the opposite direction (i.e., from Figures 11 to 9 to Figure 8 advancing). Since the distal end of the vacuum channel 3 is subject to the positive pressure of the patient and the positive pressure generated by the increased volume as the crushed tube rebounds, the fluid column retracts proximally into the vacuum channel 3, and when the compression roller 60 is released from the vacuum tube 2 to stop blocking the vacuum channel 3, the vacuum from the vacuum pump 80 proximal to the controller 10, placed within the vacuum channel 3, automatically re-establishes and aspirates the fluid column through this section of the vacuum tube 2 within the controller 10.

[0158] As described herein, the vacuum tube 2 is sized to be placed against the compression floor 26 on one side, and the point contact of the compression roller 60 with the outer surface of the vacuum tube 2 is only slightly sufficient to grip the vacuum tube 2, but substantially does not reduce the cross-sectional area of the vacuum channel 3. In embodiments where the vacuum tube 2 is not fixed within the handle base 20, the compression roller 60 is provided with a biasing device (not shown) that rotationally biases the compression roller 60 to Figure 2 the position shown. This biasing compensates for the case where the vacuum tube 2 does not contact the compression roller in the unactuated position of the compressor-actuator 40.

[0159] With the described configuration, the controller 10 will be used with the vacuum tube 2 as a thrombus removal aspiration catheter or as part of it. Regarding Figure 14 and 15This use is described, where the vacuum chamber 3 is shown as a suction controller that spirals distally through the vasculature and up to a thrombus 4 in the form of a blood clot, which is lodged within or at the distal opening of the vacuum channel 3. Proximally of the controller 10, the vacuum channel 3 is fluidly connected to a vacuum pump 80. As described above, the thrombus is typically captured at the end of the suction catheter, and the entire catheter is removed from the patient when the situation is not ideal. The present inventors have found that the use of the controller 10 can prevent the removal of the catheter. More specifically, when the distal end of the vacuum tube 2 is blocked by a thrombus, the controller 10 is actuated to block all flow through the vacuum channel 3. This occurs when the compressor - actuator 40 moves towards the handle base 20 for the first time. The controller 10 is actuated to shift the fluid column distally by a displacement distance 70. This imparts a controlled reverse flow to the fluid column within the vacuum channel 3, which causes the thrombus to translate slightly distally relative to the distal opening of the vacuum channel 3 to the specified displacement distance 70. In the third and final stage, the user releases the actuation of the controller 10 to reset the fluid column within the vacuum channel 3 and again allow free fluid flow. The present inventors have found that this movement causes repositioning of the thrombus or deformation of the thrombus or both, and this movement allows the thrombus to fully enter and pass through the vacuum channel 3, which was not possible previously.

[0160] Regarding Figure 24 The system cycle diagram of... illustrates the operation of the controller 10.

[0161] · State 1: Normal suction is occurring. The vacuum channel 3 is unblocked. The controller 100 is in a resting state where the vacuum pump 80 is connected to the vacuum channel 3.

[0162] · Transition A – Block: The thrombus 4 blocks the distal end of the vacuum channel 3. The clearing controller 10 is actuated to block the vacuum channel 3 and stop the vacuum flow distal to the controller 10.

[0163] · State 2: Flow through the vacuum channel 3 has stopped.

[0164] · Transition B – Clear: The controller 10 continues to be actuated to cause a reverse flow in the vacuum channel 3 for a metered volume column displacement.

[0165] · State 3: Flow reversal stops.

[0166] · Transition C – Return column displacement: By reconnecting the vacuum pump 80 to the vacuum channel 3, the controller 10 is reversed to return the column and accelerate the thrombus 4 into the catheter tip.

[0167] · Return to State 1 and repeat: Normal suction occurs.

[0168] The present inventor further discovered that a greater acceleration of the thrombus into the catheter provides proportionally faster aspiration. The impact velocity of the thrombus and thus the magnitude of its kinetic energy (when it impacts the distal end of the aspiration catheter) affects the amount of thrombus that deforms to fit the diameter of the vacuum channel 3. When the catheter is extended to a thrombus stuck in a blood vessel (e.g., a blood vessel in the brain), no controller 10 is required until the thrombus 4 is stuck at the distal opening of the vacuum channel 3. Thus, the thrombus has no distance to move to accelerate towards the opening of the vacuum channel 3. The imparted displacement distance of the thrombus maximizes the kinetic energy of the thrombus when it impacts the end of the catheter. The acceleration of the thrombus (and thus its kinetic energy) is generated by the pressure difference between the intracranial pressure and the effective aspiration pressure at the distal end of the catheter. To accelerate the thrombus, it and the fluid column within the catheter system must reach a certain velocity. After the catheter is blocked, the fluid velocity within the catheter is essentially zero. In a conventional catheter configuration, the pressure attempting to accelerate this fluid column is provided only by an external vacuum pump. However, it is noted that this pressure is reduced by the head loss in the tubing connecting the vacuum pump to the proximal end of the catheter. Thus, the conventional catheter must be completely withdrawn from the vasculature because the thrombus is blocked within the distal opening of the vacuum channel.

[0169] This drawback is eliminated by the controller 10. After the distal opening of the vacuum channel 3 is blocked by the thrombus, the fluid velocity within the catheter is essentially zero. The controller 10 is used to clear the vacuum channel 3 and expel the thrombus 4 distally from the distal opening. Then, the controller 10 reapplies the vacuum. After the vacuum is reapplied, the fluid column accelerates and the thrombus 4 accelerates back into the vacuum channel 3. At such acceleration, the thrombus deforms to a diameter that can be aspirated. With one or just a few applications to displace the thrombus displacement distance 70 through the controller 10, the vacuum channel 3 becomes clear and the thrombus 4 accelerates sufficiently to pass through and be completely aspirated from the vacuum tube 2. Using the controller 10, the head loss in the tubing is minimized, thus allowing the thrombus to accelerate to a much greater extent than in a conventional product configuration.

[0170] Recognizing that proximal acceleration of the thrombus is a desirable characteristic, the acceleration in the proximal direction can be enhanced when the controller 10 undergoes deactuation to re - establish the vacuum. To maximize the acceleration of the thrombus and the fluid column within the vacuum channel 3 for the purpose of maximizing the acceleration of the thrombus when it collides with the distal end of the vacuum tube 2, Figure 16The illustrated vacuum booster 100 is fluidly connected to the vacuum passage 3 of the vacuum tube 2. Generally, the vacuum booster 100 applies suction to the fluid column in the region proximal to the aspiration catheter to maximize the acceleration of the fluid column of the catheter at a user-selected time. This exemplary embodiment of the vacuum booster 100 includes a booster body 110 defining a plunger bore 112, a plunger 120 received within the bore 112, and a biasing device 130. The plunger bore 112 is shaped to define a vacuum chamber 114 and an ambient chamber 116. In the exemplary embodiment, the vacuum chamber 114 is cylindrical and has a first inner diameter, and the ambient chamber 116 is cylindrical and has a second inner diameter greater than the first inner diameter. The volume of the vacuum chamber 114 is less than the volume of the ambient chamber 116.

[0171] The plunger 120 has a vacuum piston 122 and an ambient piston 124, and the ambient piston 124 is connected to the vacuum piston 122 by a rod 123. In the exemplary embodiment, the diameter of the vacuum piston 122 is substantially equal to the first inner diameter of the vacuum chamber 114 and is capable of moving within the vacuum chamber 114. The diameter of the ambient piston 124 is substantially equal to the second inner diameter of the ambient chamber 116 and is capable of moving within the ambient chamber 116. There is a pressure chamber 118 between the vacuum piston 122 and the ambient piston 124, and the rod 123 (e.g., in the shape of an asymmetric dumbbell) connecting the two pistons 122, 124 is located in the pressure chamber 118. To seal the pressure chamber 118 from both the vacuum chamber 114 and the ambient chamber 116, a vacuum seal 126 is provided between the vacuum piston 112 and the wall of the vacuum chamber 114, and an ambient seal 128 is arranged between the ambient piston 124 and the wall of the ambient chamber 116. The booster body 110 defines a pressure chamber 118 and a pressure port 119, and the pressure port 119 fluidly connects the pressure chamber 118 to a booster control valve or switch 150. This connection is illustrated in Figure 23 FIG.

[0172] The vacuum chamber 114 is operably in communication with the vacuum passage 3 at a connection 140. The plunger 120 and the biasing device 130 are arranged such that when the biasing device 130 is in a relaxed state, the vacuum piston 122 is at a given distance from the connection 140 to the vacuum passage 3; this relaxed state is shown in Figure 17 FIG. In the relaxed state, the spring is in a stable state - no potential energy is stored in the spring. Regarding pressure, in the relaxed state, both the pressure chamber 118 and the ambient chamber 116 are at ambient pressure, i.e., they are substantially equal. When the plunger 120 moves towards the vacuum passage 3 into an energized state (as shown in Figure 16When in the state shown (e.g., in the form of a stretched spring), the biasing device 130 thus stores strain energy that is directed to move the plunger 120 away from the connector 140. When such movement occurs, this movement creates a suction force within the vacuum chamber 114 and the vacuum passage 3 that communicates with the vacuum chamber 114.

[0173] For an embodiment of the pneumatically actuated vacuum booster 100, the pressure chamber 118 is connected to a vacuum pump 80 (vacuum source) via a relatively high impedance conduit 152. The pressure chamber 118 is also connected to a boost control valve 150, which is connected to ambient pressure but is normally open to prevent flow from the pressure chamber 118 to the environment (Patm). When the vacuum booster 100 is in the cocked state ( Figure 16 ), the boost control valve 150 is open (as shown), and thus, the vacuum pump 80 can significantly reduce the pressure within the pressure chamber 118. When the boost control valve 150 is actuated (i.e., the pressure chamber 118 is connected to the surrounding environment), pressure equalization occurs between the pressure chamber 118 and the ambient chamber 116. The impedance of the connection between the pressure chamber 118 and the boost control valve 150 is designed to be substantially less than the impedance between the pressure chamber 118 and the vacuum pump 80, such that rapid pressure equalization can be achieved when the boost control valve 150 is actuated (i.e., closed).

[0174] Regarding Figure 24 the system cycle diagram illustrates the operation of the vacuum booster 100.

[0175] · State 1: Normal suction is occurring. The vacuum passage 3 is unblocked. The controller 100 is in a stationary state with the vacuum pump 80 connected to the vacuum passage 3. The vacuum booster 100 is in the cocked state. The thrombus trap 200 is operating without exhaust purification.

[0176] · Transition A – Blocked: A thrombus 4 blocks the distal end of the vacuum passage 3. The unclogging controller 10 activates to block the vacuum passage 3 and stop the vacuum flow distal to the controller 10.

[0177] · State 2: Flow through the vacuum passage 3 has stopped.

[0178] · Transition B – Unblocked: The controller 10 continues to actuate to cause reverse flow within the vacuum passage 3 for a metered volume column displacement.

[0179] · State 3: Flow reversal has stopped.

[0180] ·Transitional C - Vacuum Boost: Actuate the vacuum booster 100 to restart the flow in the nominal direction and accelerate the thrombus 4 into the catheter tip. Shortly before, simultaneously, or shortly after this, the controller 10 opens the vacuum channel 3 to restart the vacuum pump 80 to cause fluid flow and aspirate the thrombus 4 into the thrombus trap 200. Simultaneously or afterwards, the thrombus trap 200 is subjected to controlled or automatic purification to allow inspection of the thrombus 4.

[0181] ·Return to State 1 and Repeat: The vacuum booster 100 and the self - purifying trap 200 are deactivated. Normal aspiration occurs.

[0182] During the occlusion and column shift phases in the operation of the controller 10, the plunger 120 remains in the actuated state, and the elevation of the plunger 120 brings the vacuum piston 122 closer to the connector 140. During or immediately after the reverse phase, the plunger 120 is released, creating suction in the local communication cavity of the vacuum channel 3, thereby accelerating the liquid column proximally in the vacuum direction. The fluid that starts to be drawn in or towards the vacuum chamber affects the efficiency of the vacuum booster 100. More specifically, if the fluid only reaches from downstream of the vacuum booster 100 when the vacuum booster 100 is actuated, the fluid column will not be accelerated proximally as desired. When the controller 10 occludes the vacuum channel 3, the fluid entering and towards the vacuum chamber 114 will essentially reach from upstream of the vacuum channel 3, thereby accelerating the fluid column in the desired direction. In the intermediate phase where the fluid reaches from both upstream and downstream, the downstream portion can be restricted, for example, by placing a check valve (not shown) between the thrombus trap 200 and the connector 140, especially between the connector 140 and the controller 10. The check valve can be external, or the blocking function of the dredging handle can be used.

[0183] The following description summarizes the forces in the pneumatic embodiment of the vacuum booster 100. In the non-erected state of the plunger 120, the pressure chamber 118 and the ambient chamber 116 are at ambient pressure and the biasing device 130 is substantially in a relaxed state, thus storing little or no strain energy. In the erected state of the plunger 120, the boost control valve 118 causes the pressure in the pressure chamber 118 to be significantly lower than the pressure in the ambient chamber 116. The geometries of the chambers 114, 116, 118 and the pistons 122, 124 and the characteristics of the biasing device 130 are selected such that in this configuration, the force generated by the pressure difference across the (larger) ambient piston is significantly greater than the force required by the expansion spring. Thus, when a given pressure is maintained, the piston and spring system transitions upward to the "erected" position. When the vacuum booster 100 is actuated, the pressure chamber 118 is allowed to rapidly equalize with ambient pressure. In the absence of a net force input from the ambient piston 124 (the larger of the two pistons), any movement of the piston and spring system is now caused by the action of the biasing device 130 and the pressure difference across the smaller vacuum piston 122. The geometries of the chambers 114, 116, 118 and the pistons 122, 124 and the characteristics of the biasing device 130 are selected such that in the erected configuration, the restoring force of the biasing device is much higher than the counterforce caused by the pressure difference across the smaller vacuum piston 122, the restoring force being set between the ambient pressure and the pressure in the vacuum passage 3. Thus, when the vacuum booster 100 is actuated and the pressure chamber 118 is allowed to equalize with ambient pressure, the piston and spring system drives "downward" as much as possible, thereby creating a negative displacement and a significant pressure drop within the vacuum chamber 114 and thus within the vacuum passage 3 of the aspiration device.

[0184] As shown herein, current thrombus removal devices cannot inform the surgeon that the thrombus has been cleared without completely withdrawing the device from the patient's anatomy. The surgeon has no ability to observe the reservoir where the aspirated contents are stored, not only because the reservoir is located outside the sterile field in the operating room environment, but also because the removed thrombus is present within the large volume of blood contained in the reservoir.

[0185] To overcome the inability to visualize the actual retrieved thrombus, a visualization-assisted thrombus trap 200 is provided and shown in Figures 18 to 21 . The thrombus trap 200 is placed in line with the aspiration system, particularly the vacuum passage 3. In an exemplary embodiment, the thrombus trap 200 is near the catheter operator, between the aspiration catheter and the vacuum source, particularly between the controller 10 and the vacuum pump 80, such that the surgeon can see the thrombus trap 200 when using the controller 10. In use, all aspirated material flows through the thrombus trap 200.

[0186] The thrombus trap 200 includes: a container having an inflow portion 210 with an input orifice 212 fluidly connected to the vacuum channel 3; a transparent intermediate trap portion 220 in which thrombi are trapped; and an outflow portion 230 fluidly connected to the vacuum pump 80. In operation, the aspirated material and fluid travel through the controller 10 from the vacuum channel 3 through the inflow portion 210 and into the trap portion 220. The trap portion 220 contains a trap filter 222 which, in one exemplary embodiment, is a screen or filter through which all the aspirated flow must pass. The filter 222 is configured to block and capture thrombus material therein, but allow air and fluid to pass therethrough with minimal impedance, and thus flow out from the outflow portion 230 to the vacuum pump 80 and any associated vacuum pump reservoir 82. In Figures 18 to 22 the exemplary embodiment, the filter 222 is in the form of a grid or screen having apertures large enough for fluid and air to pass through, but small enough to substantially prevent thrombi from traversing the filter 222 from the inflow or trap chamber 224 of the trap portion 220 to the outflow chamber 226 of the trap portion 220. As used herein, the term "filter" includes any structure capable of separating fluid from particulate matter by preventing a particular substance from passing through while allowing the fluid to pass through the structure. Other exemplary embodiments of the filter 222 include porous polymers, textiles, or sintered semi-permeable polymers. The outflow portion 230 has an output orifice 232 which fluidly connects the outflow chamber 226 to the vacuum pump 80 to directly receive the generated vacuum.

[0187] During the surgical procedure, the container of the thrombus trap 200 is sealed when closed and in use. In one exemplary embodiment, the thrombus trap 200 can be disassembled and opened to remove thrombi from the trap chamber 224 and examined by a surgeon or pathologist, and for sterilization when the thrombus trap 200 is reusable.

[0188] Note that when the thrombus 4 is trapped in the trap chamber 224, the trap chamber 224 is also filled with blood whether or not the vacuum is still being applied. Thus, even if the overall thrombus trap 200 is transparent for the user to observe the interior, the thrombus 4 cannot be visualized. To assist in visualizing the thrombus 4 contained within the trap chamber 224, the thrombus trap 200 is configured to temporarily clear itself of fluids that visually impede the examination of the trapped thrombus material. Thus, in one exemplary embodiment, the inflow portion 212 is formed with an intake bleed valve 214 that fluidly connects to the vacuum channel 3 and the trap chamber 224. The bleed valve 214 is configured to operate in a closed mode and in a bleed mode, in which in the closed mode any flow of air and / or fluid through the bleed valve 214 and into the trap chamber 224 (or the vacuum channel 3) is completely restricted, and in the bleed mode the bleed valve 214 sucks in fluid, particularly ambient air. (Alternatively, if desired, in the bleed mode, the bleed valve 214 can suck in a transparent liquid, such as saline). During operation in the closed mode, the outlet of the bleed valve 214 is closed and the aspirated material flows unimpeded from the input orifice 212 through the thrombus trap 200 and exits from the output orifice 232 towards the vacuum source, thus leaving the aspirated thrombus and other solid materials in the trap chamber 224. Thus, when the surgeon has trapped the thrombus 4 in the trap chamber 224 during a thrombus removal procedure, the surgeon can immediately visualize the thrombus 4 by setting the bleed valve 214 to the bleed mode, since the size of the input opening of the bleed valve 214 is relatively large and since the opening to the ambient air reduces the resistance to the vacuum, causing the vacuum pump to quickly suck the ambient air into the trap chamber 224, thereby discharging all fluids from the trap chamber 224. During the examination, the bleed valve 214 can be configured to block the fluid connection between the trap chamber 224 and the vacuum channel 3. Actuation of the bleed valve 214 can be separated from or mechanically connected to the controller 10 such that when the controller 10 is in an unactuated state where suction is occurring, the bleed switch on the controller can activate the bleed valve 214. The rapid inflow of air into the trap chamber 224 is guided by the pressure drop gradient between the external environment and the relatively low pressure present within the volume existing between the trap chamber 224 and the vacuum pump 80. Thus, when the bleed valve 214 is opened, the air flow displaces the liquid from the volume of the thrombus trap 200, filling the volume mostly with transparent air rather than opaque blood. This temporary transparency allows for easier examination of the material trapped by the filter 222. The surgeon can then see the thrombus 4 unobstructed within the trap chamber 224. During this examination, control of the exhaust valve 214 (which can be mechanical or a processor-based controller) can cause the vacuum pump 80 to reduce the vacuum or shut off completely, at least until the surgeon is ready to continue the thrombus removal procedure (if continuation is desired).Normal suction is resumed when the bleed valve 214 is set back to the closed mode and the trap chamber 224 is reconnected to the vacuum channel 3. Alternatively, the bleed valve may be connected to a fluid flush line, such as a saline drip bag.

[0189] Examination of the thrombus 4 can be enhanced by providing the thrombus trap 200 with an optical filter optimized for visual contrast, the transparent trap attachment, a built-in magnification or visualization system, illumination, and / or a sensor-based thrombus detection method.

[0190] In an exemplary configuration, the vacuum booster 100 is disposed upstream of the thrombus trap 200 and on the side of the controller 10 opposite the thrombus trap 200, as Figure 21 shown. Thus, in order to maintain the efficacy of the thrombus trap 200 as the endpoint for all aspirated thrombi 4, a vacuum booster configuration that may entrap or significantly damage or macerate the thrombus is less desirable. One exemplary embodiment of a milder vacuum booster 200, rather than Figure 16 and 17 the piston design, couples a portion of the conduit of the vacuum tube 2 having a deformable internal volume with a mechanical actuation mechanism. This mechanism is capable of contracting and expanding the internal cross-section of a certain length of the vacuum channel 3 to increase or decrease the pressure along that length. Another mechanical embodiment of a vacuum booster without pneumatic actuation derives the energy for vacuum boosting from the energy imparted by the actuation of the controller 10 or from a separate energy input. For example, when the user presses a lever in the controller 10 that obstructs flow and temporarily causes a column displacement, the movement of the lever also erects and releases a spring-loaded piston that generates vacuum boost. Another exemplary embodiment of a vacuum booster is to place a screen between the vacuum chamber 114 of the vacuum booster 100 and the vacuum channel 3 of the aspiration system. This screen allows fluid communication between the two internal volumes but blocks particulate matter from entering the piston bore defined by the vacuum chamber 114. Another exemplary embodiment to prevent thrombus blockage / accidental maceration changes Figure 16 and 17 the piston configuration by making the connection member 140 a flexible diaphragm mechanically disposed between the surface of the vacuum piston 122 and the opening into the vacuum channel 3. For example, the diaphragm may be contained within and span the actual opening of the vacuum channel 3. Such a membrane transmits volume displacement while excluding all flow. The membrane may be separate from, fluidly coupled to, or attached to the vacuum piston 122. In each of these configurations, the volume through which the fluid column flows is unobstructed whether the vacuum booster 100 is in an energized state or at rest to prevent the thrombus 4 from being trapped or damaged as it passes through.

[0191] Both the vacuum booster and the blood purification clot trap rely on the timely and controlled application of vacuum or ambient pressure to specific parts of the device, namely the bleed valve 214 of the thrombus trap 200 or the plunger 120 of the vacuum booster 100. The self-clearing thrombus removal aspiration catheter described and shown herein can be provided with additional features actuated by the same user input as the self-clearing function, e.g., at the controller 10 or via user input to the controller 10, but additional conduits for opening or blocking the vacuum or atmospheric air pressure to control device features such as the self-purifying thrombus trap 200 and / or the vacuum booster 100.

[0192] The vacuum channel 3 of the vacuum tube 2 (and any other conduits within the catheter) can be coated with a hydrophobic coating, such as carnauba wax, to reduce head loss during aspiration.

[0193] Using a suitable pressure sensor (e.g., a piezoelectric diaphragm sensor, an electromagnetic diaphragm sensor, a strain gauge diaphragm sensor, or a MEMS pressure integrated circuit sensor), the controller 10 can determine when the vacuum channel 3 is blocked by a thrombus and automatically execute the clearing procedure described herein. In one exemplary embodiment, a computer connected to the sensor can detect a pressure drop and insufficient flow associated with a thrombus blockage within or at the vacuum channel 3. When a blockage is detected, the sensor triggers a sequence to stop applying vacuum in the vacuum channel 3 and executes a column shift sequence. Regarding visualization of the thrombus 4 in the device, another exemplary embodiment of the sensor includes an optical sensor that detects the presence of thrombus in either or both of the distal opening of the vacuum channel 3 and the thrombus trap 200. In the latter configuration, the optical sensor associated with the trap portion 220 detects when the thrombus 4 is present and causes fluid purification by opening the bleed valve 214.

[0194] As described herein, the vacuum tube 2 can be made of various materials. Some materials used for the vacuum tube 2 have relatively low compressive strength, such as latex, silicone, and other synthetic rubbers. Other materials used for the vacuum tube 2 have relatively high compressive strength, such as polyurethane and polyvinyl chloride. Since the vacuum tube 2 within the controller 10 expands under positive pressure and contracts under negative pressure in the vacuum channel 3, this flexible characteristic of the material used to manufacture the vacuum tube 2 may reduce effective column shift. To reduce these effects of pressure (positive and negative pressure) on the vacuum tube 2, the vacuum tube 2 can be reinforced with a braid or coil or other mechanical structure to support that portion of the vacuum tube 2 within the controller 10 from the influence of pressure changes. In the case where the vacuum tube 2 is made of a material with relatively low compressive strength, the cross-section of the vacuum tube 2 located within the controller 10 is made as short as possible to minimize the expansion / contraction effect.

[0195] Figure 22 is shown Figure 1An alternative embodiment of the controller 10 that operates the vacuum channel 3 indirectly through the compression roller 60. In Figure 22 In an exemplary embodiment, the extruding compressor is replaced with a volume change controller 300 for the vacuum channel 3 that is directly fluidly connected to the vacuum tube 3. The volume change controller 300 has a barrel 310 that has an interior 311 and defines an input hole 312 that is fluidly connected to the vacuum channel 3. The barrel 310 also defines a plunger hole 314, a pump hole 316, and a purge hole 318. A plunger 320 is sealingly connected to the interior 311 of the barrel 310 and is movable toward and away from the input hole 314. When in Figure 22 the position shown, the vacuum applied by the vacuum pump 80 is connected to the distal opening of the vacuum channel 3 for sucking materials. When a blood clot is blocked at the distal opening, the surgeon presses the plunger 320 inward. In the first part of the inward movement, the surface of the plunger 320 seals the pump hole 316 to stop applying vacuum to the vacuum channel 3. In the second part of the inward movement, the plunger 320 moves all the fluid contained in the interior 311 and the vacuum channel 3 distally to cause column displacement. Reversing the plunger reverses the column displacement and reapplies vacuum to the vacuum channel 3.

[0196] The plunger 320 can also be used to control the purging of the blood clot trap 200. The plunger is equipped with a purge conduit 322. When the plunger 320 is placed in the purge position, the plunger 320 closes the vacuum channel 3 from the vacuum pump 80 and fluidly connects the pump hole 316 to the purge hole 318 through the purge conduit 322. In this position, the fluid (e.g., ambient air) connected to the purge hole is sucked into the blood clot trap 200 through the purge conduit 322 and the purge hole 318.

[0197] Regarding Figure 24 The system cycle diagram of shows the operation of the volume change controller 300.

[0198] · State 1: Normal suction is occurring. The vacuum channel 3 is not blocked. The volume change controller 300 is in a stationary state where the vacuum pump 80 is connected to the vacuum channel 3.

[0199] · Transition A – Blocked: A blood clot 4 blocks the distal end of the vacuum channel 3. The controller 300 is actuated (inserted) to block the vacuum channel 3 and stop the vacuum flow distal to the controller 300.

[0200] · State 2: The flow through the vacuum channel 3 has stopped.

[0201] · Transition B – Unblocked: The controller 300 continues to insert to create a reverse flow in the vacuum channel 3 for a metered volume column displacement.

[0202] · State 3: The flow reversal stops.

[0203] · Transitional C – Return Column Shift: By reconnecting the vacuum pump 80 to the vacuum channel 3, the controller 300 reverses to return the column and accelerates the thrombus 4 into the catheter tip.

[0204] · Return to State 1 and Repeat: Normal aspiration occurs.

[0205] Figures 25 to 41 An exemplary embodiment of a thrombus aspiration removal system 400 that begins operation with automatic, rapid, and repetitive pressure changes is shown. The aspiration catheter 410 is Figure 26 schematically shown in, and extends from the distal orifices of a pair of valves 420, 440 (in this exemplary embodiment, pinch valves 420, 440). One of these valves is the pinch valve 420 for controlling vacuum flow and is connected between the aspiration catheter 410 and an aspiration pump (such as the vacuum pump 80). The other of these valves is the pinch valve 440 for controlling exhaust flow and is connected to a supply of exhaust fluid. In one exemplary embodiment, the exhaust fluid can be any one of albumin, d5W water, saline, half - saline, and lactated Ringer’s solution. The exhaust fluid can also be any other biocompatible fluid, such as a contrast agent or tissue - type plasminogen activator (tPa). With this fluid, the catheter 410 can perform different functions. For example, switching the exhaust fluid to a contrast agent after the clot is thought to have been successfully removed allows the surgeon to inject the contrast agent into the blood vessel to confirm that the clot has been removed. This is important because the catheter 410 changes from an aspiration function to a contrast agent injection function without any significant movement within the vasculature. For a standard aspiration catheter with a clot lodged distally, the entire catheter needs to be removed from the patient, and if a contrast agent injection is needed at that site, a catheter needs to be re - introduced through the vasculature for visualization. The exhaust fluid can be at atmospheric pressure or at a pressure above or below atmospheric pressure.

[0206] In one exemplary configuration, these valves 420, 440 are mounted to a base 401. Operably associated with the pinch valves 420, 440 are respective cams, a vacuum cam 430 and an exhaust cam 450. These cams 430, 450 are connected to a camshaft 460. A first shaft end 462 of the camshaft 460 is fixedly connected in a freely rotatable manner to a shaft bearing 470. The shaft bearing 470 has a bearing body 472 mounted to the base 401. A second shaft end 464 of the camshaft 460 is connected to a shaft drive assembly 500. The shaft drive assembly 500 includes a motor 510, a transmission or gearbox 520, a coupling 530, and a motor controller assembly 550.

[0207] The transmission 520 has an output shaft 522. To connect the transmission 520 to the camshaft 460, the first coupler end 532 of the coupler 530 is connected to the output shaft 522, and the second coupler end 534 of the coupler 530 is connected to the second shaft end 464. In this way, the rotation of the motor 510 corresponds to the rotation of the camshaft 460 (based on the gears of the transmission 520 at the same or different speeds) and the corresponding rotations of the vacuum cam 430 and the exhaust cam 450.

[0208] The control of the motor 510 is derived from the motor controller assembly 550, which includes a controller 560, a position encoder 570, and a position reset assembly 580. In one exemplary embodiment, the controller 560 is a microcontroller that has a user interface (UI) including user inputs, which include, for example, control buttons for operating the thrombectomy system 400 in various states. Examples of the control buttons are described in further detail below. The controller 560 with the UI is illustrated Figure 30 in the figure. To isolate the components from the fluid, in this exemplary embodiment, the motor 510, the transmission 520, the coupler 530, and the motor controller assembly 550, 560, 570, 580 are contained in the motor assembly housing 552. The connection of the motor assembly housing 552 to the camshaft 460 is fluid-sealed with a shaft seal 554. Similarly, the cams 430, 450, the camshaft 460, and the shaft bearings 470 are covered by the cam housing 466. The controller 560 is Figure 30 shown as separate (wired or wireless) from the motor assembly housing 552, but can also be integrated into or attached to the motor assembly housing 552. In a wireless configuration, the controller 560 can be an application on a computer or smartphone, for example, and all UIs can be accessed through a touch screen.

[0209] The vacuum cam 430 and the exhaust cam 450 are rotationally fixed to the camshaft 460. These cams 430, 450 have various cam profiles to operate the valves 420, 440. It is desirable to know the exact rotational position of the cams 430, 450 and thus the camshaft 460 so that the controller 560 can set the valves 420, 440 to any desired state. Since the motor 510 rotates freely and can end its rotation in any rotational position, it is desirable to know the exact rotational position of the camshaft 560 at all given times. Therefore, the motor controller assembly 550 includes a position encoder 570 associated with the motor 510. Through this association, information about the exact rotational state of the camshaft 460 and thus the cams 430, 450 is provided to the controller. The position encoder 570 includes an encoder disk 572 and an encoder circuit 574. The encoder 570 is capable of detecting and reporting to the controller 560 the current relative rotational position of the motor 510 at any point in time.

[0210] Those skilled in the art know that the motor 510 and / or the position encoder 570 may drift during use. To account for and correct any drift, the motor controller assembly 550 includes a position reset assembly 580. The position reset assembly 580 designates a single rotational position of the camshaft 460 as the reset point, and whenever this position crosses the zero line, the position encoder resets the position of the motor 510 to zero, which in turn allows the system to know the absolute position of the camshaft 460. In one exemplary embodiment, the position reset assembly 580 includes a photodiode 582 and a flag or interrupter 584. As Figure 30 shown, the flag 584 is fixed to the coupling 530. The photodiode 582 is placed in the path of the flag 584 such that the camshaft 460 interrupts the photodiode 582 once each time the flag 584 rotates. This exemplary embodiment allows for immediate correction of any skipped steps of the encoder 570.

[0211] An exemplary embodiment of the pinch valves 420, 440 uses the exhaust pinch valve 440 for reference Figures 31 to 33 for explanation. Each valve 420, 440 includes a valve body 422, 442 that defines a vacuum chamber 424 or an exhaust chamber 444. Elastic tubes 426, 446 are fixed at both ends of the tubes 426, 446 within the chambers 424, 444. Exemplary embodiments of this connection include, but are not limited to, fusion, compression sealing, and fixing with an adhesive. Thus, the tubes 426, 446 extend through the extent of the chambers 424, 444, and the middle portions of the tubes 426, 446 are not attached to the chambers 424, 444. The chambers of the tubes 426, 446 fluidly connect the distal ends ( Figure 31 and 32 to the left) of the chambers 424, 444 to the proximal ends ( Figure 31 and 32 to the right) of the chambers 424, 444. The middle portions of the valve bodies 422, 442 define follower connectors, and the cam followers 421 are movably fixed within the follower connectors. A first end of the cam follower 421 is biased against the outer surfaces of the cams 430, 450 by a biasing device (not shown) or is simply captured in place. The opposite second end of the cam follower 421 abuts the middle portions of the tubes 426, 446. Thus, when moved towards the tubes 426, 446 by the cams 430, 450, as Figure 32 shown, the cam follower 421 fluidly seals the chambers of the tubes 426, 446, and when the cam follower 421 is allowed to return from the tubes 426, 446, as Figure 31 shown, the cam follower 421 opens the chambers of the tubes 426, 446. In this exemplary embodiment, the cam follower 421 is pill-shaped, but it can be formed in any shape that provides the function of closing the tubes 426, 446.

[0212] The vacuum line 402 and the ventilation line 404 are both connected to the proximal end of the aspiration catheter 410 through selectively open valves 420, 440. In operation, the vacuum cam 430 and the exhaust cam 450 push their respective cam followers 421 downward, and the cam followers 421 squeeze downward short sections of tubes 426, 446 that are fluidly connected to the vacuum line 402 and the exhaust line 404, respectively. When the vacuum line 402 is open and the ventilation line 404 is closed, vacuum is drawn into the aspiration catheter 410. When the distal end of the catheter 410 is blocked by a clot, the closure increases the vacuum level inside the catheter 410 to full (the maximum current vacuum generated by the vacuum pump). This closure creates a pressure difference (delta in pressure) between the lumen of the catheter 410 and the external environment of the catheter 410, which radially and longitudinally squeezes the body of the catheter 410 downward (e.g., the diameter and length gradually decrease). This change also withdraws a small volume of fluid from the lumen of the catheter 410. In one exemplary embodiment, this volume is approximately 0.2 ml. The ultimate effect is to create a spring-like force inside the catheter 410 that wants to expand the catheter 410 back to its stable state, but this cannot happen when the vacuum line 402 is closed. Thus, the vacuum is stored as potential energy until the ventilation line 404 is opened (e.g., as can be seen in Figure 26 where the vacuum line 402 and the ventilation line 404 are connected together distal to the valves 420, 440). When the ventilation line 404 is opened, there is an influx of fluid due to the pressure difference (pressure delta). This influx of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the liquid column in the catheter 410 distal to the valves 420, 440. The momentum causes a small amount of liquid to flow through the distal portion of the catheter 410 and causes a small distal movement of the clot stuck in the distal opening at the end of the catheter 410. Once the clot is no longer stuck in the distal opening, it can move proximally along the catheter 410 and through the catheter 410 with the subsequent application of vacuum to the catheter 410. Repeatedly and selectively actuating the vacuum and exhaust impregnates the clot at the distal opening, thereby reforming it into a state in which the clot can be fully drawn into the lumen of the catheter 410 and out of the blood vessel. In this exemplary embodiment, the forward flow of fluid is intentional, which is in contrast to other exemplary embodiments herein where there is substantially no forward flow.

[0213] System 400 can operate in various modes to remove clots in blood vessels. The rotation of the cam is measured in degrees, and a full rotation is a movement of 360°. In a first exemplary embodiment, the vacuum cam 430 is configured to create a vacuum in the catheter 410 through a rotation of approximately 220°. The exhaust cam 450 is configured to have an exhaust function through a rotation of approximately 80°. The construction of cams 430, 450 stops the exhaust and vacuum simultaneously between their respective applications of vacuum and exhaust, e.g., a rotation of 30°. Thus, this construction results in the operating states according to Table 1 below.

[0214] Table 1

[0215] Status Vacuum Exhaust Cam Angle Closed 0 0 0 to +30 Vacuum 1 0 +30 to +250 Closed 0 0 +250 to +280 Exhaust 0 1 +280 to 0

[0216] As long as the exhaust is open, there is an influx of liquid to balance the vacuum pressure, then the exhaust line 404 closes and the vacuum line 402 opens, thereby suddenly causing a rapid pressure drop, which is used to strongly pull the clot into the catheter. Thus, it is desirable to close both the vacuum line and the exhaust line simultaneously before restoring the vacuum.

[0217] In another exemplary embodiment, the vacuum cam 430 is configured to create a vacuum in the catheter 410 through a rotation of approximately 220°. The exhaust cam 450 is configured to open the exhaust through a rotation of approximately 80°. Thus, in an ideal second exemplary construction, a pause is created between the vacuum suction in the catheter and the exhaust of the catheter, and another pause is created between the exhaust of the catheter and the restoration of the vacuum in the suction catheter. In this exemplary construction, the pause can be through a rotation of approximately 30°. To create a purging state in which the vacuum and exhaust occur simultaneously, the exhaust cam 450 has a small inward indentation in the position of the exhaust cam 450, which occurs during a long vacuum-on phase (e.g., between +30° and +250°). The degree of exhaust is configured not to provide a significant change in pressure or a change in vacuum energy, but rather to create a single rotational position of cams 430, 450 at which the motor control assembly 550 can stop the rotation of the camshaft 460 in the direction in which both the vacuum line 402 and the vent line 404 are connected to the catheter 410, which allows the user to purge any air that may be present in the system (e.g., in the vacuum line 402, the vent line 404, and / or the catheter 410). The degree of the indentation can be such that it only partially opens the exhaust to reduce the amount of exhaust liquid inhaled during this purging state. Such purging can be a known position of the cam rotation and is placed at this position to ensure that all lines in the system 400 are purged of air. Such a construction results in the operating states according to Table 2 below.

[0218] Table 2

[0219] Status Vacuum Exhaust Cam Angle Closed 0 0 0 to +30 Vacuum 1 0 +30 to +120 Purge 1 1 +120 to +140 Vacuum 1 0 +140 to +250 Closed 0 0 +250 to +280 Exhaust 0 1 +280 to 0

[0220] A third alternative configuration for operating system 400 may include full-time vacuum with pulsed exhaust, including operating states according to Table 3 below.

[0221] Table 3

[0222] Status Vacuum Exhaust Cam Angle Vacuum 1 0 0 to +120 Purge 1 1 +120 to +150 Vacuum 1 0 +150 to 0

[0223] A configuration opposite to the Table 3 state may include full-time exhaust with vacuum overlap.

[0224] A fourth alternative configuration for operating system 400 may include vacuum during exhaust, the configuration including operating states according to Table 4 below.

[0225] Table 4

[0226] Status Vacuum Exhaust Cam Angle Purge 1 1 0 to +30 Vacuum 1 0 +30 to +250 Closed 0 0 +250 to +280 Exhaust 0 1 +280 to 0

[0227] A configuration opposite to the Table 3 state may include full-time exhaust with vacuum overlap.

[0228] A fifth alternative configuration for operating system 400 may include exhaust during vacuum, the configuration including operating states according to Table 5 below.

[0229] Table 5

[0230] Status Vacuum Exhaust Cam Angle Closed 0 0 0 to +30 Vacuum 1 0 +30 to +250 Purify 1 1 +250 to +280 Exhaust 0 1 +280 to 0

[0231] In a further alternative configuration, there may be variable overlap of exhaust and vacuum, which would remove one or more off states from any of the above state tables.

[0232] The cam-driven valves 420, 440 allow the position encoder-driven motor to create positions for vacuum, exhaust, closure, and purge. The motor controller assembly 550 allows the cams 420, 440 to be controlled at any frequency. For example, they can be set to move through various states at any given speed, such as 4 Hz. The frequency at which the motor operates may be more suitable to operate at a lower frequency, such as 0.5 Hz, 1 Hz, or 2 Hz. Alternatively, operating at a higher frequency such as 8 Hz, 12 Hz, or 16 Hz may be more efficient. The motor control assembly 550 can also dynamically change the rotational rate of the camshaft 460 to sweep the rotational frequency. In an exemplary embodiment, the step of the speed is in the range of 1 Hz to about 4 Hz, the change in increment is between about 0.25 seconds to about 5 seconds, and the rotational range is between about 2 Hz to about 12 Hz. An example of the step, increment, and range is, in the following process 2 Hz / 4 / 6 / 8 / 10 / 12 / 10 / 8 / 6 / 4 / 2 / …, 2 Hz, 1 second increment. Another example is, in the following process 4 Hz / 8 / 12 / 8 / 4 / ..., 4 Hz, 0.5 second increment. In an exemplary embodiment, the system uses a higher frequency in the range of 8 Hz to 12 Hz, and less movement of the proximal end of the clot stuck at the distal end of the conduit 410 has been observed. Alternatively, additional increments can be used to sweep the frequency in complex forms, such as sine, sawtooth, stepped, and pulse variations.

[0233] In an exemplary alternative to the pinch valves 420, 440, these valves can be solenoid-driven pinch valves or voice coil actuators. In another exemplary alternative, rotary needle valves can be used, as Figures 42 to 46 shown. For example, the first valve state shown in Figures 42 to 44 can be a vacuum open / exhaust closed state, and the second valve state shown in Figure 45 and 46 can be a vacuum closed / vent open state.

[0234] It has been determined that a rapid start for vacuum and exhaust is desirable. To achieve such a rapid start, the cams 430, 450 initiate vacuum and exhaust respectively with cliffs 452 in the shape of the cams 430, 450. The sudden generation of vacuum rapidly reduces the pressure within the conduit 410, which will attract the clot actively against the distal end of the conduit 410. As described above, the exhaust generates distal momentum, loosening the clot, and the repetition of vacuum and exhaust results in mechanical impregnation of the clot at the distal opening until the clot fully enters the lumen of the conduit 410 and is removed from the vasculature. Thus, the present system 400 can be described as a Rapid Onset Aspiration Repeater or ROAR.

[0235] The control performed by the motor controller assembly 550 has selections of user-actuated buttons. In one exemplary embodiment, one button shuts off both the vacuum and the exhaust, i.e., the off operation. One button causes the vacuum to occur in a continuous manner, i.e., manual control. One button causes the exhaust to occur in a continuous manner, i.e., manual control. One button causes the camshaft 460 to rotate the cams 430, 450 to a position where the vacuum line 402 and the vent line 404 can be purged, i.e., the purge function. One button causes the system to repeatedly run or pulse according to a desired set of states (e.g., according to any one of Tables 1 to 5) and selections of any number of sets of step sizes, increments, and ranges. Thus, if a surgeon wishes to use the system 400 as a simple thrombus removal device, the surgeon can use only the vacuum button. In this case, the encoder 570 helps rotate the camshaft 460 to the position where the vacuum is open. The vacuum pump operates at full open vacuum until the surgeon releases the button. For example, if a surgeon wants to purge or inject contrast, then the surgeon can use the exhaust button to cause the encoder 570 to assist in rotating the camshaft 460 to the position where the exhaust port is open. Similarly, the off button rotates the camshaft 460 to the position where the cams 430, 450 close both the vacuum line 402 and the vent line 404. The purge button rotates the camshaft 460 to the position where the cams 430, 450 allow both the vacuum and the exhaust simultaneously.

[0236] In an exemplary embodiment of the run or ROAR mode, the rotation of the camshaft 460 is between about 0.5 Hz and about 25 Hz, further between about 6 Hz and about 16 Hz, and especially between about 8 Hz and about 12 Hz. In this exemplary ROAR cycle, the camshaft 460 rotates between about 10 seconds and about 30 seconds, and during that time, the motor controller assembly 550 causes the motor 410 to sweep through frequencies between about 2 Hz and about 12 Hz.

[0237] As described above, the flexible tubes 426, 446 are connected to the distal and proximal positions of the valve cavities 424, 444. The compliance of the system 400 distal to the vacuum valve (which, as described above, includes the reduction in the diameter and / or length of the catheter 410 and the compliance of the tubes 426, 446) determines how much liquid is withdrawn when the system 400 is under full vacuum and conversely how much fluid rushes back into the system 400 when that state is released when a vacuum is applied to the catheter 410 and a clot is stuck at the distal end. In other words, as the compliance distal to the valves 420, 440 increases, the momentum imparted to the stuck clot by the fluid column increases. It is desirable to minimize the amount of momentum transferred from the fluid column to the stuck clot to sufficiently loosen the clot such that the next vacuum cycle will immerse the clot at the distal end of the catheter 410, cause it to enter the lumen of the catheter 410 and be removed from the blood vessel. To minimize this compliance (which is fixed for a given catheter 410), such tubes 426, 446 are made as short as possible while still allowing valve operation by the cam followers. The compliance used herein refers to the mechanical compliance of the catheter 410 and the tubes 426, 446; it does not refer to any air that may be in the system 400, which is purged as specified herein prior to use. This desire to reduce compliance is one reason for the valve system to be directly connected to the proximal end of the catheter 410. This close connection minimizes the overall compliance. In an exemplary embodiment, the valve system may be located remote from the catheter 410 and in such a case, it is desirable to use tubes that are substantially non-compliant. Such a configuration may have lower performance due to excessive compliance.

[0238] To determine the status of the clot at the distal end of the catheter 410, the system 400 is placed in the ROAR mode. Without a sensor associated with the system 400, the surgeon cannot distinguish whether the clot is blocked during ROAR. The surgeon must turn off ROAR and observe whether the catheter is blocked (nothing is aspirated into the catheter 410) or unblocked (blood is aspirated into the catheter 410). For different scenarios based on flow and pulsation abatement pulses until unblocked, it is difficult to know when the clot is blocked.

[0239] The exhaust pipeline 404 is connected to an exhaust liquid reservoir (not shown), which can hold any one of, for example, albumin, d5 water, normal saline, half-normal saline, and lactated Ringer's solution. As described above, when the system 400 is purged with liquid, all air can be removed from the system 400. Additionally, knowing the use of a given amount of exhaust liquid at various stages of thrombus removal can allow the user to correlate the removal of a clot into the catheter after it becomes stuck distally with the exhaust liquid usage rate. In other words, the amount of exhaust liquid when the clot is blocked is different from the amount of exhaust liquid when the clot is not blocked. Therefore, the user or sensor can view or measure the use of the exhaust liquid to determine when to shut down the system. If the catheter 410 is aspirated without being blocked (unstoppered), a large amount of blood will flow out of the system 400. If the catheter 410 is aspirated while stoppered, no blood will appear at the vacuum outlet. During ROAR operation and when the catheter 410 is unstoppered, the user / sensor will detect some blood at the vacuum outlet. Finally, during ROAR operation, when the catheter 410 is stoppered, the vacuum outlet will receive some liquid, which is a combination of blood and exhaust liquid, and in this state, the flow rate of the exhaust liquid can indicate whether the catheter is stoppered or unstoppered.

[0240] If the surgeon observes free flow during vacuum and sees a captured clot (e.g., in the thrombus trap 200), the surgeon can use the catheter 410 to perform a contrast injection without moving or removing the aspiration catheter 410 to confirm revascularization. This is in stark contrast to current state-of-the-art aspiration catheters, where in the prior art catheters, the catheter removes the clot by keeping it blocked at the end, and the surgeon retracts the entire catheter to drag out the blocked clot. By sucking in a larger amount of the clot into the catheter, a smaller diameter catheter has an enhanced ability to completely uptake or ensure a better grip on the clot, which is a significant advantage. Many clots are deep within the anatomy, and it is difficult to insert a large catheter into the clot site. If a smaller diameter catheter can be made more effective through ROAR, more clots can be accessed and retrieved.

[0241] Note that an ideal goal achieved using the system 400 is to completely uptake the clot and bring it back to a standard canister (in a typical thrombus removal end reservoir) or into the thrombus trap 200. When using a standard aspiration canister and the thrombus trap 200, the system 400 can use exhaust liquid instead of air to flush the thrombus trap 200 through the intake deflation valve 214. This can maintain the vacuum pressure in the suction canister.

[0242] Now turning to an embodiment that produces maceration but no forward flow, Figure 47Illustrate an exemplary embodiment of a thrombectomy aspiration system 600 operating in ROAR mode. The system 600 includes a vacuum source 610 fluidly connected to the input port of a controllable vacuum valve 620. (For clarity, Figure 47 components of the vacuum source 610, such as a collection tank, are not shown in

[0243]

[0244] Figure 47 but are described in detail below.) The vacuum valve 620 is fluidly connected to the vacuum input port 632 of a manifold 630. The connection can be direct or through a conduit, such as a silicone tube. An exhaust fluid source or reservoir 640 containing exhaust liquid 642 is fluidly connected to a controllable exhaust valve 650. For example, the exhaust liquid 642 can be any one of albumin, d5 water, normal saline, half-normal saline, and lactated Ringer's solution. As used herein, "controllable" means that the device is capable of selecting between various states, the selection including analog and / or digital switching. An exemplary embodiment is digital switching between an open position and a closed position using a single command (e.g., a change in a bit 1 / 0). During use, the entire working channel of the thrombectomy aspiration system 600 should be free of air or other bubbles.

[0243] The exhaust fluid source 640 has a sufficient amount of exhaust liquid in the reservoir that does not terminate during a given surgical procedure, which prevents any possibility of air entering the system. If the exhaust fluid source 640 is flexible, such as having fluid supplied by a parenteral fluid containment bag or an intravenous therapy bag, the gas-free container will contract as the exhaust liquid 642 is used. If the exhaust fluid source 640 is non-flexible and has an air pocket or air bladder, such as in a replaceable / removable and sterilizable container, the conduit transferring the exhaust liquid 642 from the exhaust fluid source 640 to the exhaust valve 650 is at a level within the reservoir that keeps the input port of the conduit submerged in the exhaust liquid 642 throughout the given procedure.

[0244] The ROAR catheter 660 defines a working lumen 662 that fluidly connects its distal end 664 to a proximal manifold connector assembly 670 at the proximal end of the ROAR catheter 660, which will be described in more detail below. The ROAR catheter 660 is configured to operate in relatively small blood vessels. Thus, in one exemplary embodiment, the inner diameter of the lumen is between about 0.038” and about 0.106”, particularly between about 0.068” and about 0.088”. The proximal manifold connector assembly 670 fluidly connects the lumen 662 to the interior of the manifold 630. Thus, the manifold 630 fluidly connects the lumen 662 to a vacuum source 610 via a vacuum valve 620 and fluidly connects the lumen 662 to an exhaust fluid source 640 via an exhaust valve 650. When used within a blood vessel, the lumen 662 is filled with a liquid column having a proximal portion and a distal portion. Depending on the circumstances of use with respect to the catheter 660, the proximal and distal portions of the liquid column can be a given quantity (e.g., less than 20 microliters or less than 5 microliters), can be a given length (e.g., a few millimeters or a few centimeters), or can be an instance of the column approximated by using statistical flow analysis. For example, when discussing whether the distal portion of the liquid column exits the distal end 664 of the lumen 662, the distal portion is a measurable distance at the distal end of the liquid column and is equal to an instance of the liquid present at the plane of the distal outlet of the lumen. In the field of statistical analysis in this example, the distal portion is the last distal finite element in a finite element analysis (FEA) of the liquid column. Here, the system 600 is used to substantially prevent forward flow. The term “forward flow” is used herein to define the amount of liquid in the lumen 662 that exits the distal end 664 in the distal direction. Forward flow is defined as a fluid greater than 6 microliters (ID 0.071”, catheter length approximately 1 mm = 5.7 μL). Lesser amounts of forward flow are also included in this definition. For example, the amount of forward flow can be limited to no greater than 2 microliters, or in a particularly advantageous embodiment, the forward flow is approximately 0 microliters. In each case, no forward flow means that substantially no liquid exits the distal end 664 in the distal direction.

[0245] Operation of the aspiration thrombectomy system 600 occurs via a controller 700, which can be an analog controller or a digital controller. An example of an analog controller is shown in Figures 25 to 46Below, an example of a digital controller will be described in more detail. An exemplary construction of the digital controller is a microcontroller manufactured by Microchip Technology, Inc. The controller 700 is operably connected to each of the vacuum valve 620 and the exhaust valve 650 (and to a vacuum motor as described below). The controller 700 selectively opens and closes the vacuum valve 620 and the exhaust valve 650 such that when the vacuum valve 620 is open, the vacuum source 610 is fluidly connected to the liquid column in the chamber 662, and when the exhaust valve 650 is open, the exhaust liquid 642 is fluidly connected to the liquid column in the chamber 662. The timing of these valves is important such that the controller 700 can vary the vacuum level at the distal end 664 and prevent the distal portion of the liquid column in the chamber 662 from leaving the distal end 664 - with substantially no forward flow. When operating the valves 620, 650, there are two important actions that contribute to forward flow: the compliance of the conduit system and the water hammer effect. Each will be discussed in turn. Exemplary constructions of the vacuum valve and the exhaust valve are shown in Figures 25 to 36 and Figures 42 to 46 The constructions of these valves include spool valves, pinch valves, rotary valves, and rotary valves with a pintel design.

[0246] To explain the valve timing for eliminating forward flow, first refer to the system shown in the figure of Figure 47 Note that the ROAR conduit 660 is a flexible body and thus has compliance in both the radial and longitudinal directions. When the distal end 664 is blocked by a thrombus (as shown in Figure 47As shown, a vacuum is applied to chamber 662. Thus, the compliance of catheter 660 causes a reduction in the diameter of the catheter and a reduction in the length of the catheter. When catheter 660 is blocked, no flow occurs in the chamber. By making the pressure in chamber 662 lower than atmospheric pressure, catheter 660 contracts and decreases (radially and longitudinally). This contraction is like a spring pressing down in the lumen of the catheter. In other words, it is the storage of potential energy. If the vacuum source is then cut off (e.g., vacuum valve 620 is closed) and exhaust valve 650 is opened to exhaust fluid source 640, catheter 660 elongates and acts as a piston pulled towards exhaust liquid 642. Additionally, exhaust liquid 642 is at a higher pressure than the fluid in chamber 662 (e.g., atmospheric pressure or slightly elevated by having a higher physical location than the patient). Thus, a quantity of exhaust liquid 642 enters manifold 630 through exhaust valve 640 and then enters chamber 662 through proximal manifold connector assembly 670. When exhaust liquid 642 flows in and catheter 660 expands to its normal or free stable state, a momentum directed distally is created in the fluid column, here called a pressure pulse or pressure wave. In other words, a "pressure pulse" or "pressure wave" is the momentum within the fluid column that can be used to move the distal portion of the fluid column in the catheter lumen distally out of the distal end of the catheter. This term refers to a given cycle of vacuum valve 620 and exhaust valve 650 and is not limited to a single pressure transfer having that cycle. Thus, a pressure pulse can include multiple pressure differences having a given cycle of vacuum valve 620 and exhaust valve 650. Thus, by adjusting the timing of the vacuum valve and the exhaust valve to match the compliance and length of a particular catheter system (which can include the catheter, as well as manifolds, valves, and other chambers consistent with the catheter), the ROAR effect of this catheter can be achieved. Specifically, one way to achieve the ROAR effect and prevent the distal portion from flowing forward out of the distal end during each cycle is by adjusting the timing of exhaust valve 650.

[0247] Prior art thrombus aspiration removal systems periodically open and close a vacuum valve. While the vacuum valve is open and a vacuum is applied to the fluid column, fluid rushes into the distal end of the catheter. When the vacuum valve closes, the liquid surging proximally through the lumen is stopped by impacting the closed vacuum valve. This results in a pressure build-up at the vacuum valve and generates a rebound wave that carries momentum distally towards the distal end and ejects a quantity of fluid distally from the distal end of the catheter. This action is known as the water hammer effect. The prior art repeatedly opens and closes this vacuum valve. As a result, a quantity of liquid is periodically ejected from the distal openings of these devices. This forward flow phenomenon is undesirable in the thrombus removal region because when the liquid is allowed to be ejected from the distal end and the doctor brings the distal end close to the thrombus, the liquid may or will move the thrombus further distally, or it can cause the thrombus to break up and the arterial blood pressure will push the broken fragments further downstream, e.g., into smaller cerebral artery vessels. Therefore, in a thrombus aspiration removal system, it is desirable to completely prevent any distally-directed pressure pulses from reaching the distal end of the aspiration catheter. As described herein, system 600 has a response to the water hammer effect that is tuned to achieve maximum water hammer effect without causing forward flow, which response achieves the most effective engagement and disruption of the thrombus.

[0248] The proximal pressure measurement device 690 and the distal pressure measurement device 692 are as Figure 47 shown. In this exemplary embodiment, the proximal pressure measurement device 690 is adjacent to or within the proximal manifold connector assembly 670 and / or within the proximal portion of the fluid column, and the distal pressure measurement device 692 is adjacent to or within the distal end 664 or within the distal portion of the fluid column. Exemplary embodiments of the measurement devices 690, 692 include pressure sensors manufactured by TransducersDirect.com.

[0249] Measurements in the fluid column of catheter 660 at or near manifold 630 and near distal end 664 reveal a time delay in the travel of the pressure pulse – the pressure first rises at manifold 630 and then the pressure rises at distal end 664. By knowing the time delay and the distance between the sensors, the wave speed can be calculated. By knowing the distance from the most distal sensor to the end of catheter 660, the time it takes for the wave to travel to the distal end can be calculated. The controller can use this information to appropriately time the valve to stop the pressure pulse. If the pressure pulse is allowed to travel all the way to distal end 664, the distal portion of the fluid column in chamber 662 will leave distal end 664, e.g., flow forward. If during this time, distal end 664 is blocked by thrombus 4, this pressure pulse can or will eject thrombus 4 distally. Alternatively, if distal end 664 is approaching thrombus 4, any pressure pulse leaving distal end 664 can or will move thrombus 4 further distally. Movement of thrombus 4 in the distal direction before or after being trapped and blocked at distal end 664 of catheter 660 should be avoided. Therefore, the pressure pulse needs to be reversed or stopped before it reaches a point where it can move thrombus 4 further downstream or away from distal end 664 in the distal direction. This reversal is referred to herein as “quelling” the pressure pulse.

[0250] Operation of the thrombectomy system 600 with the ROAR effect does not produce the same results as prior art catheters. When operating with distal end 664 unobstructed, vacuum valve 620 and exhaust valve 650 are periodically opened and closed. While vacuum valve 620 is open and vacuum is applied to the fluid column, fluid rushes into distal end 664 of catheter 660 and the canister of vacuum source 610. When vacuum valve 620 closes, the sudden stop of flow creates a pressure wave due to the water hammer effect of the closing of vacuum valve 620 as described above. Controller 700 is timed to control vacuum valve 620 and exhaust valve 650 to produce the ROAR effect even when distal end 664 is open to the vasculature, and thus, any distally directed pressure pulse in thrombectomy system 600 is quelled, resulting in substantially no forward flow during the thrombus removal process. By experiment, the net flow of fluid at distal end 664 remains positive in the proximal direction – in other words, when operating with the ROAR effect in either the occluded or unoccluded state, fluid either moves toward the vacuum source through distal end 664 (when unobstructed) or does not flow at all (when obstructed). In both cases, substantially no fluid leaves distal end 610.

[0251] To achieve the ROAR effect, the change in vacuum level at the distal end is at least about 15 inHg, further at least about 20 inHg, and in particular at least about 25 inHg. The time for the change in vacuum level at the distal end from low to high or from high to low is no greater than about 50 ms, further no greater than about 30 ms, and particularly no greater than about 20 ms. This change can be referred to as the maximum pressure difference. Various combinations of these variables include a vacuum level change of about 15 inHg and a change time no greater than 50 ms, or a vacuum level change of about 20 inHg and a change time no greater than 30 ms, or a vacuum level change of about 25 inHg and a change time no greater than 20 ms.

[0252] In an exemplary embodiment according to Figure 48 the graph, the ROAR catheter 660 is operated to dampen all pressure pulses. The state of the vacuum valve 620 is shown in the waveform at the top of the graph, and the state of the exhaust valve 650 is shown in the waveform at the bottom of the graph. In this exemplary embodiment, the repeating cycle starts at time 0 as the valves begin to open. At time 1, the vacuum valve 620 is fully open while the exhaust valve 650 is closed. The vacuum continues until time 2, at which point the vacuum valve 620 begins to close. The closing of the vacuum valve 620 is not instantaneous, and thus, the vacuum valve waveform decreases at an acute angle and is fully closed at time 3. After the vacuum valve 620 closes, at time 4, the exhaust valve 650 begins to open. The closing of the vacuum valve 620 initiates a water hammer, and the closing of the vacuum valve 620 and the subsequent opening of the exhaust valve 650 cause the exhaust liquid 642 to enter the manifold 630 (and possibly the proximal end of the cavity 662). Due to the pressure change from the negative pressure generated by the vacuum source 610 to the relatively large pressure (e.g., arterial) present in the exhaust fluid source 640, the potential energy stored in the compliant catheter 660 is also allowed to be released. This combination of events initiates a pressure pulse at time 2, which travels distally through the cavity 662 towards the distal end. If there are no further changes to the valves 620, 650, the liquid in the column will spray out from the distal end 664, i.e., flow forward. However, as Figure 48 shown, after a relatively short exhaust opening time compared to the vacuum opening time, the exhaust valve 650 closes (at time 7), and shortly thereafter, the vacuum valve 620 opens. This means that while the pressure wave travels distally along the length of the cavity 662 of the catheter 660, the switching of these valves 620, 650 causes the exhaust liquid 642 to stop entering the manifold 630 and moves the fluid in the manifold 630 and the cavity 662 proximally into the collection tank 612 of the vacuum source 610 (see, for example, Figure 55)。Therefore, a reverse momentum is generated within the fluid column. This reverse momentum is large enough to prevent the pressure pulse from reaching the point where the distal portion of the fluid in the chamber 662 exits the distal end 664, thereby calming the pressure pulse and preventing forward flow. Thus, the ROAR effect can maintain the pressure level at the distal end at a level less than or equal to the physiological pressure. Figure 48 Region 690 of the two waveforms shown includes the time when the pressure pulse has been calmed. The waveforms repeat in a periodic manner to continue the distal-then-proximal momentum pulses, never allowing the distal portion to exit the distal end 664 of the catheter 660. The rapid change in pressure at the catheter tip from near full vacuum to near zero vacuum is the ROAR effect. Under the ROAR effect, the pressure at the distal end 664 can rise to just less than the arterial pressure and then, due to the re-establishment of the vacuum, begin to reverse that rise. This enables the thrombectomy aspiration system 600 to approach the thrombus 4 without distal movement of the thrombus 4 and retain the occluding thrombus 4 at the distal end 664 without any distal movement of the thrombus 4 due to pressure changes within the fluid column.

[0253] Figure 49 Another exemplary embodiment of generating the ROAR effect using the catheter 660 with the vacuum valve 620 and the exhaust valve 650 is shown in the waveforms, which repeat at an exemplary rate between about 1 Hz and about 250 Hz, further between about 2 Hz and about 20 Hz, still further between about 4 Hz and about 12 Hz, and particularly between about 6 Hz and about 8 Hz. At time 1, the vacuum valve 620 is in the open / on position and the exhaust valve 650 is in the closed / off position. At about time 2, the vacuum valve 620 begins to transition to the closed / off position. At about time 3, the vacuum valve 620 is closed / off. At time 4, the exhaust valve 650 begins to open and at about time 5, the exhaust valve 650 is fully open. The exhaust valve 650 remains open while the vacuum valve 620 is closed until time 6 when the exhaust valve 650 begins to close. The exhaust valve 650 closes at about time 7. The vacuum valve 620 begins to open at time 8 and is partially open at about time 9. The vacuum valve 620 is fully open when near the bottom range in the graph. This process is repeated periodically, at 10 Hz in this example.

[0254] In the case referred to herein as static aspiration, while suction is applied to the catheter 660, the distal end 664 of the catheter 660 is pushed towards the thrombus 4. The force generated by the lower pressure in the catheter 660 on the clot 4 is equal to the pressure difference across the clot 4 multiplied by the area of the inner diameter of the catheter 660. It is this force that "sticks" the clot 4 to the distal end 664 of the catheter 660 in an attempt to retrieve the clot 4 completely.

[0255] In the ROAR cycle, suction is applied to the blood clot by rapidly opening a valve, causing the vacuum pressure to rise rapidly. Then the suction source is closed and the liquid exhaust source is rapidly opened. This eliminates the vacuum present in the catheter 660 and rapidly changes the pressure applied to the clot again. Then the exhaust valve 650 is rapidly closed and the vacuum valve 620 is rapidly opened. This cycle is repeated multiple times per second. For example, the repetition period is between about 2 Hz and about 16 Hz, particularly between about 8 Hz and about 12 Hz. When the vacuum valve 620 is opened, the rapid drop in pressure on both sides of the clot 4 causes the clot 4 to accelerate into the lumen 662 of the catheter 660. The release of the vacuum pressure when the exhaust valve 650 is opened causes the clot 4 to rebound from the catheter 660. When the vacuum is applied again, the clot 4 accelerates towards the catheter 660 again. These accelerations and rebounds cause an oscillating distributed mass of the clot 4. The large internal accelerations of the distributed mass generated by the oscillation create internal forces in the clot 4 that are high enough to exceed the tensile strength of the clot 4 and cause it to fail. Then, the fragments of the clot 4 are aspirated through the catheter 660 and into the vacuum collection canister 612. To maximize the forces in the clot, the pressure differential across the ends of the clot and the rate at which the differential is applied are maximized. The higher the rate at which the force is applied to the clot, the higher the internal acceleration of the distributed mass of the clot, and thus the higher the internal forces within the clot, and thus the higher the likelihood of the clot tearing. The time for the pressure change in both the upward and downward directions is about 20 ms. For example, at 8 Hz, each cycle is 125 ms, and at 12 Hz, each cycle is 83 ms. The higher the frequency of the cycle, the more of these impacts are generated by the interaction of the catheter and the clot. Therefore, it is better to use a higher frequency, but only up to the point where there is not enough time to generate a sufficiently effective pressure increment within each cycle.

[0256] During operation of the catheter 660 with ROAR effect, a proximal pressure measuring device 690 and a distal pressure measuring device 692 can be used to measure the pressure pulses. Figure 50 The curve diagram shows the pressure sensed by these devices 690, 692 during the exemplary 10 Hz pulse shown in Figure 49 Figure 51 shows Figure 49 and 50 ​Superimposed curves). The pressure sensed by the proximal pressure measuring device 690 starts at a lower pressure value (at approximately -13 psi), and the pressure sensed by the distal pressure measuring device 692 starts at a higher pressure value (at approximately -11 psi). This represents a partially blocked system where the incomplete seal of the thrombus mimic with the catheter allows some flow by creating a slightly lower pressure during distal measurement. At time 4, the vacuum is turned off and the exhaust valve 650 starts to open. Consequently, the vacuum in the chamber 662 starts to be released. This means that the pressure at the proximal pressure measuring device 690 starts to increase, as evidenced by the upward curve starting at approximately 4'. Shortly thereafter, as the pressure change propagates distally down the catheter 660, the pressure at the distal pressure measuring device 692 starts to increase, as evidenced by the upward curve starting at approximately 4'. At time 6, the exhaust valve 650 starts to close, and thus, no more exhaust liquid 642 enters the manifold 630 to increase or augment the fluid column in the chamber 662. Nevertheless, as the vacuum (negative pressure) is completely removed or compensated by the pressure of the exhaust liquid 642, the pressure at the proximal pressure measuring device 690 continues to rise. The pressure at the proximal pressure measuring device 690 reaches a peak, and as Figure 50 shown, the pressure at the peak is at a positive pressure of approximately 2 psi – this occurs even though the thrombectomy aspiration system 600 is not actively applying any positive pressure to the fluid or the chamber 662. Instead, this pressure level > 0.0 psi is due to the momentum of the fluid traveling within the chamber 662. Thus, the positive pressure within the chamber 662 is acceptable, but needs to be suppressed before reaching the distal end. At time 8, the exhaust valve 650 is already closed, and the vacuum valve 620 starts to open approximately at the peak pressure time at the proximal pressure measuring device 690. The opening of the vacuum valve 620 reduces the pressure within the chamber 662 and prevents any further increase in the pressure at the proximal pressure measuring device 690 (if not blocked at this level, the pressure at the distal pressure measuring device 692 could be > 0.0 psi, meaning forward flow at the distal end would flow out from the distal end). The calming of the pressure pulse is demonstrated by reviewing the pressure trace of the distal pressure measuring device 692. As in Figure 50As can be seen from the graph, the increase in pressure at the distal pressure measurement device 692 follows the increase in pressure at the proximal pressure measurement device 690. At time 8, the pressure recorded at the distal pressure measurement device 692 is still negative (about -5 psi), but it is rising. As the vacuum continues to operate and exceeds time 9 (when the vacuum valve 620 is fully open), the peak pressure measured by the distal pressure measurement device 692 at the distal end 664 is less than 0.0 psi (horizontal dashed line), which means that the pressure pulse is quenched and the liquid from the distal portion does not leave the distal end 664. In other words, there is essentially no forward flow. The ROAR effect allows the thrombus mimetic to maintain a seal on the catheter, and the system 600 is able to reach a full vacuum of -13 psi during two measurements. Since the distal pressure is almost released to zero but quickly reaches a vacuum of -13 psi, the pressure difference shown is about 13 psi.

[0257] As described herein, flow from the distal end 664 of the catheter 660 can be forced while cycling between vacuum and exhaust. The rapid switching between vacuum and exhaust creates a forward flow pressure pulse in the fluid column, which, if not controlled, will force the fluid column to leave the distal end 664 of the catheter 660. The wave travels through the fluid column at a very high speed in the medium. The speed is mainly a function of the fluid density, the system compliance (bulk modulus), and the length of the fluid column. To prevent these waves from forcing the fluid column to leave the catheter, the system is considered as a whole and the parameters of the valve switching cycle are set to control the forces that cause the fluid column to flow. To ensure that the fluid column does not leave the distal end 664 of the catheter 660, it is important to tune the catheter 660, any extension tubes connected to the catheter 660, the controller 700, and the valve sequence as a system.

[0258] The objectives of the tuning process are at least twofold: to prevent the pressure wave generated during ROAR operation from causing forward flow, and to optimize the ROAR effect. The length of the fluid column is crucial for tuning the system. The pressure wave moves rapidly within the fluid column. The time it takes for the wave to reach the distal end of the catheter is a function of that velocity and the length of the fluid column. The velocity is a function of the fluid density within the column and the bulk modulus of the catheter and extension tube. The bulk modulus refers to the compliance of the system: the radial and longitudinal flexibility of the catheter and extension tube. The density of the fluid column is not as important as the bulk modulus, unless it varies significantly, such as in the case where there are gaseous (air) bubbles in the fluid column. Therefore, it is very important to purge all air from the system before performing ROAR operation. For a given catheter and extension tube configuration, the bulk modulus and length of the system are fixed. Compliance can be added to the system to change the velocity and thus tune the timing of the pressure wave. For example, a flexible length of tubing can be added in line on a relatively rigid catheter and extension tube. When a pressure pulse occurs during ROAR operation, this flexible length of tubing expands. This reduces the bulk modulus of the system and decreases the velocity, thus slowing down the pressure wave and increasing its transit time to the distal end of the catheter. Compliance can also be increased in other ways, such as including a piston supported by a spring in a hole communicating with the catheter lumen, such that the pressure wave displaces the piston, thereby increasing the compliance of the system. By manipulating compliance and valve timing, the system can be tuned for many different combinations of catheter and extension tube. Careful tuning results in a resonant state. If the suction and release pulses in the catheter are tuned to match the natural frequency of the clot, an enhanced ROAR effect can be achieved.

[0259] Tuning can be done statically or dynamically. A system that is tuned statically is tuned such that the catheter 660 (and any extension tube attached to the catheter 660) has a fixed valve sequence (e.g., Figure 29 and 30The exemplary configuration shown in FIG. ) is coordinated with the controller 700. The controller 700 senses the presence of the catheter 660 when the catheter 660 is attached and verifies that the catheter is the correct one for the tuning sequence of the controller 700. If the correct catheter is not sensed, the tuning sequence will not be initiated. In contrast, a dynamically tuned system is tuned during operation. Before operation, a valve sequence that generates a series of pressure pulses in the catheter 660 is initiated. Sensors on the catheter 660 and / or the extension tube, such as strain gauges, detect these pulses and are used to adjust the parameters of the controller 700 operation to produce the ROAR effect. The catheter 660 contains critical data, such as its length, and transmits it to the controller 700. With this tuning, any catheter within a limited range can be used without causing the fluid column to flow out of the distal end 664 during ROAR operation. Alternatively, the catheter 660 and the extension tube can be tuned at the manufacturer, and the specific valve timing can be transmitted to the controller 700 through the catheter 660.

[0260] In an exemplary embodiment, the valve sequence is as follows:

[0261] The vacuum valve 620 is closed;

[0262] After a period of time, the exhaust valve 650 is opened;

[0263] After a period of time, the exhaust valve 650 is closed;

[0264] After a period of time, the vacuum valve 620 is opened; and

[0265] After a period of time, the sequence is repeated.

[0266] When the exhaust valve 650 is opened, a small amount of exhaust liquid 642 enters the system and generates a pressure pulse. If the exhaust valve 650 is not closed and the vacuum valve 620 is not opened before the pulse reaches the distal end 664 of the catheter 660, the fluid column will flow forward away from the distal end 664 of the catheter 660. To prevent the fluid column from flowing out of the catheter 660, the system must be tuned at the time that is the time required for the pressure pulse to traverse the catheter. In addition, the pressure pulse generated by closing the vacuum valve 620 under flow conditions will cause a pressure increase that must be quelled by opening the exhaust valve 650 before it causes forward flow.

[0267] Tuning is accomplished by selecting appropriate times for the vacuum cycle and the exhaust cycle. In this regard, the vacuum cycle includes the Vacon time 622, the Vacon duration 624, the Vacoff time 626, and the Vacoff duration 628, and the exhaust cycle includes the Vnton time 652, the Vnton duration 654, the Vntoff time 656, and the Vntoff duration 658. Thus, referring to Figure 52Explanation of tuning. The cycle time is the duration for which the entire cycle repeats. At 8 Hz, the cycle time is 125 ms, while at 12 Hz, the cycle time is 83.33 ms. The cycle time is determined by adding the first time and the second time in a cycle where the Vacon duration 624, the Vnton duration 654, and both the vacuum valve 620 and the exhaust valve 650 are closed (referred to as the "double-off" or "double-closed" time or state). The cycle time is optimized through the dynamics or resonance of a specific conduit 660. The Vacon duration 624 must be long enough for the system to evacuate to full vacuum, and the longer the vacuum duration in a specific cycle, the better the aspiration of the thrombus 4. In this embodiment, only opening the vacuum valve is referred to as the "only vacuum" state. The first double-closed time, i.e., the time from when the vacuum is off (the vacuum valve 620 is closed) until the start of exhaust (the exhaust valve 650 is opened), has an impact on the extent of forward flow. Since this is a short time, this forward flow is referred to as flow burping. Through experiments, an exemplary embodiment of a conduit 660 with a 0.071" inner diameter experiences flow burping when the first double-closed time is greater than approximately 30 ms; the longer the double-closed time, the greater the flow burping. During ROAR operation, the first double-closed time is approximately 10 ms; thus, this is significantly less than the flow burping threshold, which means that substantially all forward flow is quelled. The Vnton duration 654 is determined by the maximum time that elapses before the occluding clot 4 drops from forward flow. The ratio between the Vnton duration 654 and the second double-closed time is a compromise between the longest Vnton time 654 and the minimum of the first double-closed time. In this embodiment, only opening the exhaust valve is referred to as the "only exhaust" state. Finally, regarding the second double-closed time, the exhaust valve 650 is closed (fully closed) before the vacuum valve 620 is opened and the vacuum restarts.

[0268] Regarding Figure 53The valve position graph in further illustrates this calculation. Starting from the left side of the graph, at Vacon time 622, the exhaust valve 650 is closed and the vacuum valve 620 is open. The Vacon duration 624 is long enough to evacuate the system 600 to full vacuum (between about 10 ms and about 50 ms, especially about 30 ms). The longer the Vacon duration 624, the better the performance of the conduit 660, as the flow rate in the proximal direction increases. There is a trade-off based on obtaining a higher frequency on the clot 4 to achieve more hits / second. In one exemplary embodiment, the Vacon duration 624 calculated from Vacon time 622 to Vacoff time 626 is about 40% to about 60% of the cycle time 629. As described above, the cycle time 629 is the minimum value determined by the sum of the Vacon duration 624 plus the first double-close time 625 and the second double-close time 627 plus the Vnton duration 654. The Vnton duration 654 is short enough to fill the chamber with exhaust liquid without causing forward flow (between about 10 ms and about 50 ms, especially about 30 ms). The first double-close time 625 is set based on when the opening dynamic flow pause occurs. The maximum value of the first double-close time 625 applies to the shorter of either the period from Vacoff time 626 to Vnton time 652 or from Vacoff time 626 to Vacon time 622'. Each of these values is optimized by the dynamics / resonance / compliance / length of the specific conduit 660 and the extension device.

[0269] From this, several observations can be made. When the exhaust opens, a pressure pulse is generated. It is important to stop the pressure pulse before it reaches the distal end. If the pressure pulse is not stopped before it reaches the distal end, the conduit 660 will experience forward flow. The method of stopping the pressure pulse is to close the exhaust and / or reopen the vacuum with the exhaust closed beforehand. If the vacuum remains on, the exhaust needs to be closed. Or, if the vacuum does not remain on, the exhaust is closed and the vacuum is reopened before the pressure pulse reaches the distal end 664. In other words, the exhaust needs to be closed before the pressure pulse reaches the distal end 664, and the vacuum must be opened. Therefore, the condition of simply opening the vacuum valve 620 when the exhaust valve 650 opens may not be sufficient to quell the pressure pulse because the resistance between the exhaust and the vacuum is low; the exhaust will overwhelm the vacuum, so the vacuum will not have an effect along the entire length of the conduit. The time it takes for the pressure pulse to propagate to the end of the conduit 660 and then cause forward flow is used to define the time the exhaust valve 650 remains open. The time the exhaust remains open is chosen to be shorter than the time it takes for the pressure pulse to propagate to the distal end 664.

[0270] In Figure 55In the exemplary embodiment illustrated in the figures, all parts of the aspiration thrombectomy system 600, except for the ROAR catheter 660, are incorporated into the body 601 of the vacuum source 610. In particular, the vacuum source 610 includes a body 601, a collection canister 612, and a vacuum motor 614. The vacuum motor 614 is fluidly connected to the outlet of the collection canister 612, and the inlet of the collection canister 612 is fluidly connected to the vacuum side of the manifold 630. Thus, the vacuum created by the vacuum motor 614 imparts a vacuum to the collection canister 612 to draw fluid from the manifold 630 into the collection canister 612, but not into the vacuum motor 614. A vacuum valve 620 present at the manifold 630 prevents the input fluid received at the manifold 630 from entering the collection canister 612 and isolates the vacuum created by the manifold 630 and the vacuum motor 614. An exhaust fluid reservoir 640 containing an exhaust fluid 642 is fluidly connected to the exhaust side of the manifold 630. An exhaust valve 650 present at the manifold 630 isolates the manifold 630 from the discharge fluid 642 and prevents the fluid within the manifold 630 from entering the exhaust fluid reservoir 640 (since the pressure in the manifold 630 is typically lower than the pressure within the reservoir 640, fluid from the manifold 630 will generally not enter the reservoir 640). In summary, the catheter input port 631 of the manifold 630 is fluidly connected to the collection canister 612 via the vacuum valve 620 and to the exhaust fluid 642 within the reservoir 640 via the exhaust valve 650. The catheter input port 631 is fluidly connected to the downstream end of the proximal manifold connector assembly 670. The upstream end of the proximal manifold connector assembly 670 is fluidly connected to the proximal end of the catheter 660.

[0271] Regarding Figure 54 and 55 illustrate the direct connection of the catheter 660 to the aspiration thrombectomy system 600. The proximal manifold connector assembly 670 connects the proximal end 666 of the ROAR catheter 660 to the manifold 630. In Figure 54[[ the exemplary embodiment shown, the proximal manifold connector assembly 670 includes a male luer lock fitting 672 that is removably or integrally connected to the manifold 630 (shown in dashed lines). The assembly 670 includes a ROAR identification (ID) subassembly 680. ​An exemplary embodiment of the ID sub-component 680 shown includes an inductive sensing device or sensor 682 connected to the manifold 630. The inductive sensor 682 detects the presence of an inductive sensing portion 684 present in or integrated with the proximal manifold connector assembly 670. In one exemplary embodiment, the manifold 630 can be used with a variety of different ROAR catheters 660, each type of ROAR catheter having a unique inductive sensing portion 684, and the inductive sensor 682 of the manifold 630 is capable of determining the type of the attached ROAR catheter 660. Thus, by appropriately communicating the ROAR catheter 660 type to the controller 700, the controller 700 is able to operate the ROAR catheter 660 according to its own unique configuration, thereby generating a ROAR effect for each different ROAR catheter 660 used. Nevertheless, when the sensor 682 does not detect the sensing portion 684 and the thrombus aspiration and removal system 600 is operated, the controller 700 will automatically prevent the ROAR operation of the thrombus aspiration and removal system 600, and the connected catheter will operate only as a standard vacuum catheter.

[0272] Regarding ​ An indirect connection of the catheter 660 to the thrombus aspiration and removal system 600 is illustrated. The proximal manifold connector assembly 670 can simply be ​ the fitting 672 shown in, or it can be or can include a separate extension line 674 between the catheter input port 631 and any catheter 660 (standard or ROAR) to be used with the thrombus aspiration and removal system 600. In an exemplary embodiment of the extension line 674, the extension line 674 includes not only a lumen extension for aspiration through the catheter 600, but the extension line 674 also includes system controls for operating the thrombus aspiration and removal system 600. These controls include, for example, turning on and off the vacuum motor 614 and initiating ROAR operation (e.g., each of these has a button, or an on / off switch for the vacuum and a push-to-start button for ROAR). As ​ shown, the extension line 674 has a distal end capable of connecting to both a standard catheter and a ROAR catheter 600, as both can be used with the thrombus aspiration and removal system 600. When a standard catheter is connected to the extension line 674, the thrombus aspiration and removal system 660 operates only as a standard vacuum pump, and ROAR is disabled. When a ROAR catheter 660 is connected to the extension line 674, the identification sub-components in the ROAR catheter 660 and the extension line 674 notify the system 600 which ROAR catheter 660 and which extension line 674 are connected.

[0273] In an exemplary embodiment of a digitally controlled system having a vacuum valve 620 and an exhaust valve 650, a processor and memory in a controller 700 store identification data and, when identifying a particular ROAR conduit (e.g., different length, different outer diameter, different material), the controller 700 loads a valve sequence and operates the vacuum valve 620 and the exhaust valve 650 based on the characteristics of the particular conduit connected to a vacuum source 610. In one exemplary embodiment, identification data can be pre-programmed at the manufacturer for all currently existing ROAR conduits 660. Thus, by directly connecting the ROAR conduit 660 to the system 600, the controller 700 can operate without receiving any information other than the identity of the conduit 660. If a ROAR extension line 674 is used between the ROAR conduit 660 and the controller 700 (in other words, the extension line is ROAR-compatible and capable of informing the system 600 of its enhanced characteristics compared to the enhanced characteristics of the connected ROAR conduit 660), the controller 700 can operate without receiving any information other than the identity of the conduit 660 and the identity of the intermediate extension line 674 because the connection to the ROAR extension line 674 allows the system 600 to detect which particular one of the different ROAR conduits 660 has been connected to the distal end of the ROAR extension line 674 and then use the ROAR extension line 674 to operate ROAR in a predetermined manner suitable for that particular ROAR conduit 660. In the case of RFID or near field communication (NFC), a chip embedded in the ROAR conduit 660 is programmed with the specific valve timing required for that conduit 660. The controller 700 reads these values and acts appropriately on that conduit 660. This ensures compatibility with future new generations of conduits that require different tuning, which was unknown when programming the controller 700 at the manufacturer. If the conduit to be used is not a ROAR conduit 660, ROAR should not be used with that conduit because there is a high likelihood of forward flow at the distal end. Thus, when a non-ROAR conduit is connected to the distal end of the ROAR extension line 674 or directly connected to the system 600 or connected to the distal end of a non-ROAR extension line 674, the system 600 automatically prevents the use of the ROAR effect.

[0274] The identification sub-component includes various measures that occur at least proximally to the ROAR catheter 660 (e.g., inductive sensing systems 682, 684 or a one-wire detection system such as a DALLAS semiconductor crypto chip, RFID, Bluetooth Low Energy (BLE), metal touchpad, simple passive designs based on resistors (in series for the catheter and extension, to name a few)). In the sub-component, there can be two or more electrical contacts. For example, there can be three contacts including power, ground, and a signal using a Hall sensor. In a two-contact configuration, there can be a two-wire configuration using a resistor and a mechanical switch. The resistance between the two contacts can be measured and the state of the switch can be detected based on that resistance. For example, using the above DALLAS chip, power and signal can be combined on one line (plus an additional ground wire) to establish a "one-wire" connection. The identification sub-component can also be present at the distal connection of the extension tubing 674 (e.g., a Luer fitting) (to contact the identification sub-component at the proximal end of the ROAR catheter 660) and extend back through the extension tubing 674 to a communication connection with the vacuum source 610, e.g., the proximal manifold connector assembly 670. Thus, the thrombectomy aspiration system 600 has the ability to sense / detect when the connection of the ROAR catheter 660 is different from a standard catheter (i.e., non-ROAR). The connection of the ROAR catheter 660 enables the use of the ROAR function; the connection of a non-ROAR catheter (or, e.g., connection to the side port of a rotary hemostatic valve (RHW)) does not enable the use of the ROAR function and only normal aspiration is available. In the case where the identification sub-component includes electrical contacts in the ROAR catheter 660, the conductive connection to the vacuum motor 614 can utilize one or more coils of the ROAR catheter 660 as one of these conductors. Alternatively, two or more conductors can be wrapped within the ROAR catheter 660. Alternatively or additionally, the conductors can be incorporated on the outside of the ROAR catheter 660.

[0275] Except for exemplary embodiments in which the system 600 already stores the operating parameters for performing aspiration and automatically uses these parameters when connecting the ROAR catheter 660 and / or the extension tubing 674 or the ROAR catheter 660 or the extension tubing 674 provides the operating parameters for performing aspiration, optional programs can be provided for the user in the controller. In one exemplary embodiment, these optional programs can be programmed at the place where the controller 700 is manufactured. The user has a manual that associates the particular ROAR catheter 660 and / or extension tubing 674 being used with a code that loads operating parameters such as pressure, delay, timing. Instead of a manual, these operating parameters can be manually input by the user rather than through an optional program, for example, by reading the instructions for use (IFU) or the information on the packaging of the system 600, the ROAR catheter 660, or the extension tubing 674. Additionally, if the user has a desired method of operation (e.g., increasing a particular timing), the user can directly input the parameters through the user interface on the system 600. In other exemplary embodiments, a code provider (e.g., a QR code, a barcode, or an RFID chip) can be on the packaging of one or more components, and the user presents the code provider to the controller for reading. In this regard, the system 600 includes a barcode reader and / or a QR code reader and / or an RFID communication device. In another exemplary embodiment, using the display on the system 600, the screen presents parameters to the user, and these parameters can be fixed or changed by the user. In other words, the user can accept or change the presented parameters. In a particularly inexpensive embodiment, the parameters can be "stored" on a punch card provided by the ROAR catheter 660 or the extension tubing 674, and the system 600 has a punch card reader. In this embodiment, the user inserts the inexpensive card (e.g., provided with a covering to protect it from the liquids present in the operating room) into the card reader, and the controller 700 utilizes the parameters on the card or the code on the card, which is associated with a set of stored parameters.

[0276] All of these embodiments can present the operator with a choice of alternative procedures or parameters, or the system 600 can list the parameters to be used individually on a display screen and then allow the operator to select those parameters or change the provided parameters. Similarly, the operator can store parameters / procedures into the empty memory within the controller 700. The stored information provided by the catheter, extension tubing, card, code, etc. can be ROAR parameters, or alternatively, the information can be characteristics of the catheter and extension tubing such that the controller 700 can make compensations to provide a predetermined ROAR waveform at the catheter tip. In other words, the catheter and extension tubing do not provide a stored ROAR program, but can simply provide information to the controller 700 so that the timing and pressure of each catheter / extension tubing combination can be modified to achieve a predetermined ROAR pressure / time profile. By storing compensation parameters or actual time / pressure parameters, the controller 700 can accommodate future catheters and extensions that are not yet available. Additionally, chips, resistors, RFID, or BLE are used to prevent the system 600 from being used with catheters not provided by the manufacturer of the system 600, and / or to present a warning or alarm condition to the operator so that they are aware that the system 600 does not support the catheter and / or extension.

[0277] An exemplary embodiment of the proximal manifold connector assembly 670 includes an extension tubing 674 having a system control board 676, the system control board 676 having ​ the remote controller 678 shown. An exemplary embodiment of the remote controller 678 is a mechanical slide switch that opens or closes the vacuum based on a longitudinal position. This can be a two-position switch with a button for ROAR operation. Alternatively, a three-position switch can be provided. In the forward position, the vacuum is off; in the middle or intermediate position, the vacuum is on; in the backward position, ROAR operation occurs. When the remote switch is connected, any control buttons on the pump are disabled, but the "emergency off" switch on the pump allows the user to turn off the pump when needed, regardless of the operation of the remote controller. LEDs can be provided on the remote controller 678 and / or the body 601. For example, these LEDs can be: red = off, green = vacuum on, flashing green = ROAR, flashing red = error, blue = exhaust / purge. In an exemplary embodiment, a mechanical redundant clamping valve abuts the catheter and, when actuated, clamps the lumen of the catheter. In this exemplary embodiment, the distal end of the proximal manifold connector assembly 670 connected to the ROAR catheter 660 includes a luer lock component that connects to another luer lock component on the ROAR catheter 660. In various exemplary embodiments, the switch is passive (e.g., a simple mechanical switch) or an active switch (e.g., capacitive, pressure, magnetic). In this case, the switch is powered by wires through the extension tubing 674. In an alternative embodiment, the switch is an independent module attached to the extension tubing 674, e.g., battery-powered.

[0278] The first benefit of the thrombectomy aspiration system 600 is that, with this configuration, the same vacuum source 610 can be used with all the catheters that could previously be connected to any surgical aspiration device / vacuum pump. The second benefit relates to the safety of achieving the ROAR effect. In such a configuration, the user is persuaded to connect the proximal end of the ROAR catheter 660 to the distal end of the proprietary extension tubing 674. This is beneficial for various reasons. First, the ROAR will not function unless two unique ROAR components are directly connected and a positive ROAR ID is established. Second, if a standard rotary hemostatic valve is connected between the ROAR catheter 660 and the extension tubing 674 (for any reason that a surgeon / nurse might have), the identification will be negative and the ROAR will be disabled. The risk is that the fluid contained within the lumen of such a rotary hemostatic valve might enter the fluid column of the ROAR catheter and thus introduce air bubbles that would need to be completely removed from the system for use. The RHV 609 increases the likelihood of air remaining in the lumen or entering the fluid system. See ​ . Therefore, a particularly desirable configuration of the ROAR catheter 660 is a direct connection between the proximal end of the ROAR catheter 660 and the distal end of the proprietary extension tubing 674. There is also a safety issue of ensuring that the ROAR effect is only used with the ROAR catheter 660. As described above, each ROAR catheter 660 has a specific set of characteristics related to compliance, and thus the operation of the vacuum valve 620 and the exhaust valve 650 is set for that set of characteristics. The system 600 is configured to respond to a specific ROAR configuration based on the physical characteristics of the connected ROAR catheter 600, such as length and lumen size. Therefore, the system 660 is tuned / programmed to store a given ROAR setting for each ROAR catheter 660.

[0279] However, it is possible that new ROAR catheters 660 and new ROAR extension tubing 674 are created after the system 600 or the controller 700 is placed in the field. Therefore, providing the identity of the ROAR catheter 660 or the ROAR extension tubing 674 will not be sufficient to allow those components to operate properly. Thus, in additional or alternative embodiments, each of the ROAR catheter 660 and the ROAR extension tubing 674 is equipped with a memory device (e.g., a DS28E07 EEPROM memory chip) that, when connected to the system 600, provides the controller 700 with the variables required for the ROAR catheter 660 and / or the ROAR extension tubing 674 to operate under ROAR effects. Example variables stored in the memory of each ROAR catheter 660 and ROAR extension tubing 674 include, but are not limited to, the frequency of the waveform cycle, the time the vacuum is opened during the cycle (Vacon time 622), the duration of the vacuum (Vacon duration 624), the time the vacuum is closed during the cycle (Vacoff time 626), the duration of the vacuum closure (Vacoff duration 628), the time the exhaust is opened during the cycle (Vnton time 652), the duration of the exhaust (Vnton duration 654), the time the exhaust is closed during the cycle (Vntoff time 656), and / or the duration of the exhaust closure (Vntoff duration 658). By being able to provide such information to the controller 700, the system 600 can utilize any future ROAR catheter 660 and / or ROAR extension tubing 674 that may be created for the system 600.

[0280] An exemplary embodiment of the self - contained thrombectomy system 600 is shown in ​ . The system 600 has an external body 601 that houses a vacuum motor 614, a controller 700, and control means for the vacuum valve 620 and the exhaust valve 650 (exemplary embodiments of control means for the valves are shown in ​ and ​ ). The vacuum motor 614 is fluidly connected to a collection tank 612 (illustrated in dashed lines). The body 601 houses a set of system controls 676 (in alternative embodiments, the controls 676 may be located on / also be located on the extension tubing 674). In this exemplary embodiment, there are three buttons: "Off", "Purge", and "ROAR / Vac". (The purge function will be described in further detail below.) On the opposite side of the collection tank 612 is an exhaust fluid reservoir 640 (illustrated in dashed lines) that contains an exhaust liquid 642. As described above, the fluid path of the catheter 660 is always free of bubbles / air during the surgical procedure.

[0281] The body 601 has a cartridge connection assembly 602 on its front surface. The cartridge connection assembly 602 projects from the front surface and has an external shape substantially the same as that of the cartridge 710 to which it will be attached. The vacuum valve 620 and the exhaust valve 650 project from the front surface 608 of the cartridge connection assembly 602 and, in one exemplary embodiment, are centered within corresponding recesses of the cartridge connection assembly 602. In this embodiment, the vacuum valve 620 and the exhaust valve 650 are pistons having a clamping structure at their outermost distal ends. In this exemplary embodiment, the clamping structure is generally in the shape of a standard slot screwdriver. When the vacuum piston and the exhaust piston extend a given distance (e.g., 8 mm) from the recesses, the slot presses against the tube (in the cartridge 710) to close the cavity within the corresponding vacuum or exhaust hose. Closing the hose serves to close the corresponding valve, and releasing the hose serves to open the vacuum or exhaust, respectively. Thus, if the hoses for each vacuum line and exhaust line are placed directly in front of the pistons, the valves 620, 650 will control the vacuum and exhaust according to the ROAR process described herein. (As described below, the cartridge 710 positions those hoses in this manner.) Between the valves 620, 650 is a boss 604 that projects from the front surface 608 of the cartridge connection assembly 602. The boss 604 has an outer surface with a given shape, such as a raceway, and orientation wings 605. At the end of the boss 604 is a rotary lock 606 in the shape of a semi-circle or semi-ellipse. The rotary lock 606 has a central pivot to allow it to rotate 90 degrees from the ​ position shown. Thus, in the rotational direction, the rotary lock 606 defines a lower surface (opposite the front surface 608 of the cartridge connection assembly 602) perpendicular to the projecting extent of the boss 604. These lower surfaces are set at a distance to define a gap between the lower surface of the rotary lock 606 and the front surface 608 of the cartridge connection assembly 602. Also present on the front surface 608 of the cartridge connection assembly 602 is a conductive connector 618. The conductive connector 618 is used to detect when the cartridge 710 is present and locked onto the cartridge connection assembly 602. Detection of the cartridge 710 can be performed by mechanical means (such as spring pins) or a combination of mechanical, optical, and electrical means.

[0282] The cartridge 710 is removably connected to the cartridge connection assembly 602, and an exemplary embodiment of the cartridge 710 is shown in ​ . As ​ shown, the cartridge 710 has an internal orifice 712, the shape of which corresponds to the given shape of the boss 604. The shapes of the boss 604 and the internal orifice match such that the cartridge 710 can be fitted onto the boss 604 and slid downward thereon until the rear surface of the cartridge 710 is aligned with and / or in contact with the front surface 608 of the cartridge connection assembly 602. The rear surface of the cartridge 710 is depicted in ​ . In ​In the view of, there are pockets 714 corresponding to the shape of the orientation wing 605 in the inner surface of the cartridge 710 at the inner orifice 712. In this regard, when the cartridge 710 slides downward from the boss 604, there is only one orientation in which the cartridge 710 can approach the front surface 608 in the lowest position (e.g., in a key in a keyhole). This placement ensures that the distal effectors of the vacuum valve 620 and the exhaust valve 650 are always aligned with the vacuum valve area 720 and the exhaust valve area 750 within the cartridge 710.

[0283] When the "T" shape of the boss 604 and the wing 605 matches the inner "T" shape of the orifice 712, three connections are possible. First, as described above, the distal effectors of the vacuum valve 620 and the exhaust valve 650 are aligned with the vacuum valve area 720 and the exhaust valve area 750 within the cartridge 710. Second, the conductive connector 718 on the back surface of the cartridge 710 is aligned with and contacts the corresponding conductive connector 618 adjacent to the boss 604. These connectors 718, 618 can be, for example, corresponding pads and spring pins to ensure a positive electrical connection when the cartridge 610 is locked to the cartridge body 611 using the rotary lock 606. Through appropriate electrical connections, these connectors 718, 618 can inform the controller 700 that the cartridge 710 is installed and ready for use, and which cartridge 710 is installed if it is associated with a particular ROAR conduit 660 and identification is required. Finally, the rotary lock 606 is located above the front surface 608 of the cartridge connection assembly 602, and the bottom surface of the rotary lock 606 is located above the outer front surface 716 of the cartridge 710. The protruding distance of the boss 604 is configured to place the bottom surface of the rotary lock 606 (the surface facing the front surface 608) at a distance approximately equal to the thickness of the cartridge 710, such that as the lock 606 rotates, the bottom surface of the rotary lock 606 engages with the outer front surface 716 of the cartridge 710, thereby firmly pressing the cartridge 710 against the front surface 608 into place, bringing the connectors 718, 618 into contact with each other, and locking the cartridge 710 to the body 601. The right-angle-rotating rotary lock 606 secures the cartridge 710 to the body 601 and also provides a cam force that holds the cartridge 710 thereon, especially when the valves 620, 650 are actuated against the vacuum and exhaust pipes present within the cartridge 710. In one exemplary embodiment, a switch (not shown) is integrated into the rotary lock 606 that detects the right-angle rotation and, together with the electrical connectors 718, 618, verifies that the system 600 is equipped and ready for use.

[0284] In a particularly effective configuration, the cartridge 710 is included as ​The entire set of the junction box and tubing group shown can be removable, replaceable, and disposable. The box 710 has a set of relatively short tubing whips and extension whips. The tubing whips include a first tubing whip 722 fluidly connected to the collection tank 612 of the vacuum source 610 and a second tubing whip 752 fluidly connected to the inlet of the exhaust valve 650. The extension whip can be the extension line 674 or can be a short tube directly connected to the conduit 660. Once connected, this effective configuration allows the system of cavities to automatically purge air / bubbles. By positioning the exhaust liquid above all the cavities (e.g., with the bag 640 in ​ ), the conduit 660, and the collection tank, opening the outlet of the exhaust fluid reservoir 640 will fill all the internal cavities and purge any air / bubbles in the system before use. If desired, the cam lock can be mechanically connected to the vacuum motor 614 (temporarily or permanently), and the motor 614 can be operated to actively suck all the air into the collection tank, thereby purifying the system 600. As an alternative to the front-loading configuration of the box 710, the box 710 can be connected or molded as part of the bottom of the disposable collection tank 612. In this configuration, the two disposable components can be provided together in a sterile package and disposed of as a single unit. The exhaust fluid can be used in either a rigid container ( ​ ) or a bag ( ​ ). The exhaust fluid 642 can be part of the box 700 in which all the cavities are pre-filled with saline and part of a single disposable package. One or both of the exhaust fluid reservoir 640 and the collection tank 612 can be part of the disposable box 700 system. All the disposable components used in the catheterization process can be integrated together in a single disposable package.

[0285] As previously mentioned, it is important to purge the air in the system to achieve the ROAR effect. The purging can be achieved in several ways. The two main methods for purging the system are forced purging and dribble purging. The forced purging method involves immersing the end of the extension line 674 in a sterile fluid such as saline and activating the "purge" function while immersed. Then, the controller 700 will alternately open one or both of the control valves for a predetermined time and sequence to draw the sterile fluid through the extension line 674 and the valves and displace all the air that may be present in the system. Once this purging process is complete, the two valves are closed, and the extension line 674 with a full column of fluid can be connected to the conduit, which has also been purged and ROAR has been applied. In contrast, the dribble method relies on a small positive pressure (generated by gravity, squeezing a fluid bag, pressurizing an exhaust liquid tank, or a peristaltic pump or any similar measure) to cause the exhaust fluid to dribble through the cavities, and thus, to overflow. In an exemplary case of a dribble purging system, the exhaust fluid source 640 is above the outlet of the extension line 674, and the exhaust liquid path does not contain any air traps.

[0286] For the trickle method, the purification cycle is initiated by pressing the purification button and, in an exemplary embodiment, is executed by the controller 700. With the vacuum valve 620 closed, the vacuum source 610 is opened and the vacuum container is evacuated to the desired vacuum level. The exhaust valve 650 is opened and the exhaust liquid 642 is allowed to fill the exhaust pipe and the extension pipe 674. To ensure that all air is expelled from the manifold 630, the vacuum valve 620 is briefly opened while the exhaust valve 650 is also open. This allows the exhaust liquid 642 to be drawn from the exhaust fluid source 640 and the extension pipe 674 and through the vacuum manifold channels, thereby purging them of air. After the vacuum valve 620 is closed, the vent valve 650 remains open for a period of time to ensure that the amount of fluid removed from the extension pipe 674 by the vacuum cycle is replenished. This cycle of exhaust liquid flow and momentary vacuum can be repeated several times to ensure complete purification. The purification pump can be a peristaltic pump, a pressurized cuff around a flexible exhaust liquid container (such as an IV bag), and / or an exhaust fluid filter canister pressurized using the exhaust from the vacuum source 610.

[0287] The presence of air bubbles in the fluid system can have an adverse effect on the water hammer effect. Therefore, the system 600 facilitates or automatically purges air from the fluid chamber. In an exemplary embodiment, a bubble sensor (based on optics, ultrasound, or fluid pressure profile) is incorporated into the system 600 to facilitate this purge or to automatically effect the purge function (e.g., under the control of an operator to prevent purging when the catheter 660 is in the bloodstream). There are various measures for bubble detection. For example, an optical sensor can be placed in the cartridge 710 to sense the presence of air bubbles. Using a sensor coupled to the vacuum source 610, a slow pressure increase can be detected to prevent the use of an incorrect catheter or extension. The specific compliance of the catheter 660 or the extension pipe 674 is one of the parameters used to program or compensate the system 600. User feedback indicates to the user when the system has been adequately purified. In an exemplary embodiment, the compliance of the catheter 660 and the extension pipe 674 is controlled to be below a certain optimal range. Similarly, the pressure rise information is used to modify the ROAR settings, e.g., to detect blockages and provide an optimal pressure profile for that condition.

[0288] The exemplary configuration of the described and shown aspiration thrombectomy system 600 provides a variety of significant benefits. Before describing these additional benefits, reference ​ , ​An exemplary embodiment of a thrombectomy aspiration system 600 and a catheter 660 with an extended tubing 674 is shown. The thrombectomy aspiration system 600 includes a vacuum source 610 having a collection canister 612, an exhaust fluid reservoir 640 having an exhaust fluid 642, a manifold 630, and a proximal manifold connector assembly 670. Removably connected to the proximal manifold connector assembly 670 is a ROAR extended tubing 674. Adjacent to the ROAR extended tubing 674 is an off-the-shelf extended tubing 674', which can be used with the system and with a conventional surgical vacuum source by connecting via the proximal manifold connector assembly 670. The ROAR extension line 674 includes system controls 676, which are also shown on the top surface of the frame of the system 600. Also shown are a ROAR catheter 660 and an off-the-shelf aspiration catheter 660'. Through a proximal luer fitting, both catheters 660, 660' can be used with either extension line 674, 674'.

[0289] There are several topologies for the disposable, reusable, and limited-reuse components of the thrombectomy aspiration system 600 as described and shown herein. The vacuum source 610 can be a limited-reuse component that is inserted into a reusable electronic / power system, such as ​ the frame in. The valve element cartridge 710 includes pinch tubes and is thus a disposable component. Alternatively, the valve assembly can be reusable, for example, in cases where the valve actuator is separate, or in a separate semi-reusable module, or as part of a pump / control system. Different types of valves (e.g., rotary valves, trumpet valves) have different ways of separating the disposable / reusable parts of the system 600. The valve actuator can be part of the reusable part or part of the limited-reuse part (e.g., together with the pump module). Alternatively, or rather, the valve actuator can be a second limited-reuse module. The cartridge 710 having the valve element can include a diaphragm or piston actuated by a mechanical actuator in the reusable part of the system 600. Through this modularity, the architecture of the system 600 becomes suitable for use with any vacuum source, even a household vacuum system (which can include a vacuum pressure regulator to ensure the uniformity of the system 600). The power source of the system 600 can be a rechargeable battery or a replaceable module attached to the system 600, in which case the latter does not need to be sterile. Alternatively, the power source is a primary battery included as part of a disposable component, which can include a disposable pumping element.

[0290] Various configurations allow for multiple product topologies specifically tailored to different use cases. For example, one topology is a system with a minimum recurring cost, where only the tubing kit is disposable. Alternatively, another topology is a system that requires a minimum capital cost and incorporates modules whose costs are easily amortizable for each surgical case.

[0291] Various additional safety measures can be added to system 600. For example, a liquid level detector can be provided at or with the exhaust fluid reservoir 640 to confirm that the exhaust liquid 642 is in the tank or bag, to indicate a warning to the user when the level of the exhaust liquid is low, and to prevent operation of system 600 if the exhaust liquid is about to be depleted or is empty. In a configuration with cartridge 710, system 600 will not start unless the cartridge 710 is in place and properly installed. System 600 can have a purge function that is used to fill the various cavities of conduit 660, extension line 674, and any tubing connecting the exhaust fluid reservoir 640 and collection tank 612 prior to use. Note that system 600 should not be operated if there is air anywhere in the cavities. Thus, controller 700 can operate the system during a pre-use setup phase to draw in the exhaust liquid 642 and fill the various cavities. This can include operating the vacuum motor 614 in reverse to apply positive pressure for purging the various cavities. Alternatively, controller 700 can actuate a peristaltic pump to clear the exhaust fluid through the cavities. Controller 700 can be programmed during operation of system 600 to detect peak usage during ROAR. If these peaks are not evident, a conclusion that there is air in the system can be determined. Bubble detectors (i.e., ultrasonic) can be added to the system and placed across the tubing in the cartridge and provide feedback to the controller to ensure that the tubing has been properly purged. Using such a conclusion, controller 700 can be programmed to stop operation and initiate an automatic de-aeration procedure to flush the various cavities using an external liquid source or from the exhaust fluid reservoir 640.

[0292] Note that the various individual features of the processes and systems of the present invention may be described in only one exemplary embodiment herein. The selection of a particular description of a single exemplary embodiment herein should not be construed as a limitation that a particular feature applies only to the described embodiment. All features described herein apply equally to any or all other exemplary embodiments described herein in any combination or grouping or arrangement, are additions to these exemplary embodiments, or are interchangeable therewith. In particular, the use of a single reference numeral herein to illustrate, define, or describe a particular feature does not mean that the feature cannot be associated with or equivalent to another feature in another figure or description. Additionally, in the case where two or more reference numerals are used in a figure or drawing, this should not be construed as being limited to those embodiments or features, and they equally apply to similar features or those without the use of a reference numeral or the omission of another reference numeral.

[0293] The foregoing description and drawings illustrate the principles, exemplary embodiments, and modes of operation of the systems, devices, and methods. However, the systems, devices, and methods should not be construed as limited to the specific embodiments discussed above. Those skilled in the art will appreciate other variations of the embodiments discussed above, and the above embodiments should be considered illustrative rather than restrictive. Accordingly, it should be understood that those skilled in the art may make variations to those embodiments without departing from the scope of the systems, devices, and methods as defined by the appended claims.

Claims

1. A clot removal system, comprising: A catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion; A controllable vacuum valve; A vacuum source fluidly connected to the vacuum valve; A controllable exhaust valve having an exhaust liquid inlet; An exhaust fluid source containing exhaust liquid and fluidly connected to the exhaust valve to hold the exhaust liquid at the exhaust liquid inlet; A manifold connected to the catheter, to the vacuum valve and to the exhaust valve, the manifold fluidly connecting the proximal portion of the liquid column in the lumen: Fluidly to the vacuum source through the vacuum valve; And Fluidly to the exhaust fluid source through the exhaust valve; A controller connected to the vacuum valve and the exhaust valve and configured to selectively open and close the vacuum valve and the exhaust valve such that: In response to opening the vacuum valve, the vacuum source is fluidly connected to the liquid column in the lumen; And In response to opening the exhaust valve, the exhaust fluid source is fluidly connected to the liquid column in the lumen, The controller is configured to cyclically open and close the vacuum valve and the exhaust valve, wherein in only the vacuum state and only the exhaust state, the vacuum valve and the exhaust valve are not opened simultaneously so that during each cycle: Change the vacuum level at the distal end; And Control the forward flow of the distal portion of the liquid column at the distal end.

2. The system according to claim 1, wherein the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle including a double-closed state in which the vacuum valve is closed and the exhaust valve is closed.

3. The system according to claim 2, wherein the time of the double-closed state is not greater than 30 ms.

4. The system according to claim 1, wherein the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle including only an exhaust state in which the vacuum valve is closed and the exhaust valve is open.

5. The system according to claim 4, wherein the time of the only exhaust state is not greater than 50 ms.

6. The system according to claim 1, wherein the controller is configured to selectively open and close the vacuum valve and the exhaust valve in a repeating cycle including: Only the vacuum state, in which the vacuum valve is open and the exhaust valve is closed; A first double-closed state, in which the vacuum valve is closed and the exhaust valve is closed; Only the exhaust state, in which the vacuum valve is closed and the exhaust valve is open; and A second double-closed state, in which the vacuum valve is closed and the exhaust valve is closed.

7. The system according to claim 6, wherein the time between the opening and the closing of the exhaust valve is between 10 ms and 50 ms.

8. The system according to claim 6, wherein the period of the cycle is between 6 Hz and 16 Hz.

9. The system according to claim 6, wherein the period of the cycle is between 8 Hz and 12 Hz.

10. The system according to claim 1, wherein a change in the vacuum level at the distal end is greater than 15 inHg in a time of no greater than 50 ms.

11. The system according to claim 1, wherein a change in the vacuum level at the distal end is greater than 20 inHg in a change time of no greater than 30 ms.

12. The system according to claim 1, wherein a change in the vacuum level at the distal end is greater than 25 inHg in a change time of no greater than 20 ms.

13. The system according to claim 1, wherein: the inner diameter of the cavity is between 0.038” and 0.106”; and the controller is configured to cyclically open and close the vacuum valve and the exhaust valve at a frequency of 2 to 16 Hz.

14. The system according to claim 1, wherein: the inner diameter of the cavity is between 0.068” and 0.088”; and the controller is configured to cyclically open and close the vacuum valve and the exhaust valve at a frequency of 2 to 16 Hz.

15. The system according to claim 1, wherein the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle, and prevent forward flow of the distal portion out of the distal end during each cycle by adjusting the timing of the exhaust valve.

16. The system according to claim 1, wherein the controller is configured to cyclically open and close the vacuum valve and the exhaust valve to maintain the pressure level at the distal end below physiological pressure.

17. The system according to claim 1, further comprising a shaft, and the vacuum valve and the exhaust valve are mounted together on the shaft.

18. A clot removal system, comprising: a catheter having a distal end and defining a cavity filled with a liquid column having a proximal portion and a distal portion; a controllable vacuum valve; a vacuum source fluidly connected to the vacuum valve; a controllable exhaust valve having an exhaust liquid inlet; an exhaust fluid source containing exhaust liquid and fluidly connected to the exhaust valve to maintain the exhaust liquid at the exhaust liquid inlet; a manifold connected to the catheter, to the vacuum valve, and to the exhaust valve, the manifold fluidly connecting the proximal portion of the liquid column in the cavity: to the vacuum source through the vacuum valve; and to the exhaust fluid source through the exhaust valve; a controller connected to the vacuum valve and the exhaust valve and configured to selectively open and close the vacuum valve and the exhaust valve such that: in response to opening the vacuum valve, the vacuum source is fluidly connected to the liquid column in the cavity; and in response to opening the exhaust valve, the exhaust fluid source is fluidly connected to the liquid column in the cavity, the controller is configured to cyclically open and close the vacuum valve and the exhaust valve in a repeating cycle including a double-closed state in which the vacuum valve is closed and the exhaust valve is closed to, in each cycle: change the vacuum level at the distal end; and prevent forward flow of the distal portion out of the distal end, and the time of the double-closed state is no greater than 30 ms.

19. A clot removal system, comprising: a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion; a vacuum source; an exhaust liquid source; and a vacuum and exhaust control system configured to cyclically connect or disconnect the vacuum source and the exhaust liquid source, wherein in a only-vacuum state and a only-exhaust state, the vacuum source and the exhaust liquid source are not simultaneously connected to: change the vacuum level at the distal end; and control forward flow of the distal portion of the liquid column at the distal end of the catheter.

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